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2018 data FDA MAUDE openFDA FDA Class II

Prosthesis, Knee, Hemi-, Patellar 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 §888.3580 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#492 of 1000 · 2,066 reports · 1992–2018

  • BOOK 2,066 reports
  • RANK #492 of 1000
  • DEATH 2 death-typed
  • INJ 1,886 injury-typed
  • MALF 102 malfunction
  • SPAN 1992–2018
  • PEAK 2008: 171
  • PHOTO Handpiece

Nearest event-volume peer: Handpiece, Air-Powered, Dental (5 report gap)

Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented sits #492 of 1000 among tracked device types with 2,066 MAUDE reports spanning 1992–2018. 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 →

Injury-coded reports run above the device-type norm

Prosthesis carries 91.3% INJURY-coded reports, 61.0pp above 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 91.3% corpus 30.3% · above corpus mean (+61.0 pp)
  • MALF 4.9% corpus 64.8% · below corpus mean (-59.9 pp)

Lead product-problem code Explanted is 19% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS, INC. accounts for 67% of manufacturer-tagged reports · Top event location HOSPITAL is 49% of location-tagged rows .

Prosthesis in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented carries 2,066 MAUDE reports, ranked #492 of 1000.

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

Event Types

Injury 1,886 (91.3%)
Malfunction 102 (4.9%)
Other 49 (2.4%)
27 (1.3%)
Death 2 (0.1%)

Patient Outcomes

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

Required Intervention 1,585 (69.6%)
Hospitalization 235 (10.3%)
R 187 (8.2%)
139 (6.1%)
Other 90 (4.0%)
O 12 (0.5%)
S 7 (0.3%)
Disability 7 (0.3%)
Invalid Data 7 (0.3%)
Life Threatening 3 (0.1%)
Death 2 (0.1%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Explanted 501
Implant, removal of 396
Component(s), worn 342
Replace 242
Loose 198
Insufficient Device Problem Information 134
Naturally Worn 116
Break 103
Unknown (for use when the device problem is not known) 87
Fracture 80
Other (for use when an appropriate device code cannot be identified) 54
Material Separation 53
Component(s), broken 49
Device Issue 45
Detachment Of Device Component 36
Loss of or Failure to Bond 35
Device Slipped 32
Loose or Intermittent Connection 28
Disassembly 24
Appropriate Device Problem Term/Code Not Available 18

Yearly Trend

92
1992: 40
93
1993: 152
94
1994: 138
95
1995: 94
96
1996: 128
97
1997: 167
98
1998: 156
99
1999: 59
00
2000: 24
01
2001: 44
02
2002: 31
03
2003: 37
04
2004: 32
05
2005: 69
06
2006: 104
07
2007: 80
08
2008: 171
09
2009: 153
10
2010: 147
11
2011: 123
12
2012: 54
13
2013: 39
14
2014: 13
15
2015: 6
18
2018: 5

Reports fell to 6 in 2015, down from an average of 26 in the two years before.

Related Entities for Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented

Top Manufacturers

DEPUY ORTHOPAEDICS, INC. 603
ZIMMER, INC. 208
DEPUY WARSAW 60
STRYKER ORTHOPAEDICS MAHWAH 35

Event Locations

HOSPITAL 1,003 (48.5%)
929 (45.0%)
INVALID DATA 58 (2.8%)
HOME 24 (1.2%)
UNKNOWN 19 (0.9%)
OTHER 11 (0.5%)
NO INFORMATION 8 (0.4%)
I 7 (0.3%)
NOT APPLICABLE 5 (0.2%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis: 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 (2,066 here).

Handpiece, Air-Powered, Dental 2,071 Continuous Glucose Monitor Retrospective Da… 2,060 Ligator, Hemorrhoidal 2,058 Filler, Bone Void, Calcium Compound 2,056

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Prosthesis 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; 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.