ENCORE MEDICAL L.P.

FDA MAUDE device safety record · 2003–2026

What the Data Shows About ENCORE MEDICAL L.P.

ENCORE MEDICAL L.P. is associated with 9,982 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2003 through 2026. Of the total, 1 is coded as a death report and 9,771 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for ENCORE MEDICAL L.P. should be reviewed at the device-family level rather than company-wide. Across those devices, 4 distinct event types appear in the record, led by Injury at 9,771 reports (97.9% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 19 years of MAUDE data, with the peak single-year volume reaching 1,862 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

9,982
Total Reports
1
Death Reports
9,771
Injury Reports
20
Device Types

Event Types

Injury 9,771 (97.9%)
Malfunction 188 (1.9%)
Other 22 (0.2%)
Death 1 (0.0%)

Patient Outcomes

Required Intervention 7,648 (63.8%)
Other 1,615 (13.5%)
R 1,471 (12.3%)
Hospitalization 598 (5.0%)
O 453 (3.8%)
H 72 (0.6%)
66 (0.6%)
S 37 (0.3%)
Disability 25 (0.2%)
L 3 (0.0%)
Life Threatening 3 (0.0%)
D 1 (0.0%)
Death 1 (0.0%)

Devices (20)

Compare Shoulder Prosthesis, Reverse Configuration vs Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented →

Yearly Trend

03
2003: 1
04
2004: 7
05
2005: 12
06
2006: 2
10
2010: 26
11
2011: 1
14
2014: 1
15
2015: 2
16
2016: 6
17
2017: 760
18
2018: 861
19
2019: 1,109
20
2020: 1,083
21
2021: 872
22
2022: 1,407
23
2023: 439
24
2024: 1,215
25
2025: 1,862
26
2026: 316

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.