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2022 data FDA MAUDE openFDA FDA Class II

Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §888.3590 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Prosthesis, Knee, Hemi-, Tibial, Resurfacing LIGHT-BOOK · MAUDE

#243 of 1000 · 8,110 reports · 1992–2022

  • BOOK 8,110 reports
  • RANK #243 of 1000
  • DEATH 7 death-typed
  • INJ 6,535 injury-typed
  • MALF 1,076 malfunction
  • SPAN 1992–2022
  • PEAK 2009: 1,115
  • PHOTO Dermatome

Nearest event-volume peer: Dermatome (11 report gap)

Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) sits #243 of 1000 among tracked device types with 8,110 MAUDE reports spanning 1992–2022. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports sit below the device-type norm

Prosthesis, Knee, Hemi-, Tibial, Resurfacing carries 13.3% MALFUNCTION-coded reports, 51.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 80.6% corpus 30.3% · above corpus mean (+50.3 pp)
  • MALF 13.3% corpus 64.8% · below corpus mean (-51.6 pp)

Lead product-problem code Explanted is 29% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS, INC. accounts for 56% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .

Prosthesis, Knee, Hemi-, Tibial, Resurfacing in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) carries 8,110 MAUDE reports, ranked #243 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 6,535 (80.6%)
Malfunction 1,076 (13.3%)
Other 439 (5.4%)
53 (0.7%)
Death 7 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 4,579 (45.5%)
Hospitalization 2,139 (21.2%)
R 1,895 (18.8%)
Other 913 (9.1%)
461 (4.6%)
O 39 (0.4%)
Disability 17 (0.2%)
Invalid Data 8 (0.1%)
S 7 (0.1%)
Death 5 (0.0%)
Life Threatening 5 (0.0%)
L 2 (0.0%)

Top Product Problems

Explanted 3,753
Replace 2,113
Implant, removal of 1,487
Loose 1,419
Component(s), worn 1,351
Unknown (for use when the device problem is not known) 349
Fitting Problem 341
Break 289
Insufficient Device Problem Information 276
Other (for use when an appropriate device code cannot be identified) 219
Fracture 214
Naturally Worn 204
Device Slipped 143
Dislocated 127
Component(s), broken 123
Device Issue 120
Device remains implanted 105
Material Separation 77
Unstable 74
Loss of or Failure to Bond 53

Yearly Trend

92
1992: 16
93
1993: 146
94
1994: 118
95
1995: 67
96
1996: 241
97
1997: 557
98
1998: 509
99
1999: 272
00
2000: 196
01
2001: 808
02
2002: 437
03
2003: 284
04
2004: 228
05
2005: 372
06
2006: 496
07
2007: 648
08
2008: 879
09
2009: 1,115
10
2010: 543
11
2011: 21
12
2012: 79
13
2013: 37
14
2014: 16
15
2015: 18
17
2017: 3
18
2018: 3
22
2022: 1

Reports fell to 3 in 2018, down from an average of 11 in the two years before.

Related Entities for Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

Top Manufacturers

DEPUY ORTHOPAEDICS, INC. 1,870
ZIMMER, INC. 693
ENCORE MEDICAL, L.P. 327
STRYKER ORTHOPAEDICS MAHWAH 267
WRIGHT MEDICAL TECHNOLOGY, INC. 170

Event Locations

5,167 (63.7%)
HOSPITAL 2,671 (32.9%)
INVALID DATA 104 (1.3%)
HOME 61 (0.8%)
UNKNOWN 36 (0.4%)
OTHER 22 (0.3%)
I 16 (0.2%)
NO INFORMATION 13 (0.2%)
NOT APPLICABLE 12 (0.1%)
AMBULATORY SURGICAL FACILITY 8 (0.1%)

Compare DEPUY ORTHOPAEDICS, INC. vs ZIMMER, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis, Knee, Hemi-, Tibial, Resurfacing: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (8,110 here).

Dermatome 8,121 Accessories, Soft Lens Products 8,031 Set 8,011 Lens, Intraocular, Toric Optics 7,999

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Percutaneous Retrieval 7 Dressing, Wound, Occlusive 7 Instrument 7 Joint, Temporomandibular, Implant 7

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Prosthesis, Knee, Hemi-, Tibial, Resurfacing are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Prosthesis, Knee, Hemi-, Tibial, Resurfacing; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.