SIGMA 1024-51-500Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL TRAY UNICONDYLAR METAL BACKED SIZE 5 LM/RL · Class 2 · Implant
All models of SIGMA (380)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295002352), received between Feb 12, 2019 and Mar 9, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loss of or Failure to Bond1
Patient problems
- No Code Available1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS PAIN. DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2013, DOR: (B)(6) 2021, LEFT KNEE.
Patient problems: Pain
MAUDE report 11444304 ↗InjuryFeb 12, 2019Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THE PATIENT¿S IMPLANTS WERE REMOVED ON (B)(6) 2019, DUE TO TIBIAL LOOSENING. THE INCIDENT INVOLVED THE LEFT SIDE. THE ORIGINAL SURGERY WAS IN 2017.
Patient problems: No Code Available
MAUDE report 8332514 ↗
Other PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- INSTRUMENT I-K3834CG2LHowmedica Osteonics Corp. · PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG3RHowmedica Osteonics Corp. · PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- RESTORIS 170616Mako Surgical Corp. · PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG2RHowmedica Osteonics Corp. · PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG3LHowmedica Osteonics Corp. · PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- SIGMA 1024-51-300Depuy (Ireland) · PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- SIGMA 1024-54-307Depuy (Ireland) · PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- SIGMA 1024-07-400Depuy (Ireland) · PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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