SIGMA 1024-54-509Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 5 RM/LL 9mm XLK · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295002956), received between Nov 29, 2018 and Sep 2, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fitting Problem” (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
- Fitting Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Consequences Or Impact To Patient1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH TIBIAL INSERT EXCHANGE AND IRRIGATION AND DEBRIDEMENT TO ADDRESS A DEEP INFECTION AND SWELLING. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swelling/ Edema
MAUDE report 12413157 ↗MalfunctionNov 29, 2018Fitting Problem; Fitting Problem
ONCE IMPLANTED THE TIBIAL COMPONENT, THE SURGEON TRIED TO PLACE TO INSERT BUT BOTH DIDN'T ASSEMBLY TO THE TIBIAL COMPONENT. THE TIBIAL COMPONENT WAS REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8116341 ↗
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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