SIGMA 1024-08-500Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE PARTIAL KNEE FEMORAL UNICONDYLAR CEMENTED SIZE 5 RM/LL · Class 2 · Implant
All models of SIGMA (380)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295001812), received between Nov 6, 2017 and May 12, 2025 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Loss of or Failure to Bond2
- Difficult to Insert1
- Insufficient Device Problem Information1
- Naturally Worn1
Patient problems
- Pain5
- No Code Available2
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE POLY IMPLANT WOULD NOT FULLY SEAT WHEN IMPLANTED DURING UKA PROCEDURE. THEY TRIED A DIFFERENT IMPLANT AND IT WOULDN'T SEAT. THEY CLEARED OUT ADDITIONAL BONE AND TRIED AGAIN BUT IT STILL WOULDN'T SEAT. THEY TRIED AN IMPLANT THE NEXT SIZE UP BUT IT WOULDN'T SIT EITHER. THE DOCTOR DECIDED THAT THE BEST CLINICAL OUTCOME WOULD BE TO PUT THE SMALLER IMPLANT IN AND USE THE PATIENTS WEIGHT TO FULLY SEAT THE IMPLANT. THE FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED WITHOUT PROBLEM. THE ROBOT APPEARED TO PERFORM AS EXPECTED. THE CASE HAD ISSUES WITH SEATING THE POLY IMPLANT AFTER THE ROBOTIC STEPS WERE COMPLETED. ALL UNI IMPLANTS ARE CEMENTED AS PLANNED. THERE WAS A 40 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22004277 ↗InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAIN AND THE UNI KNEE WAS CONVERTED TO A TOTAL KNEE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.
Patient problems: Pain
MAUDE report 17624787 ↗InjuryJan 25, 2022Loss of or Failure to Bond; Loss of or Failure to Bond
LOOSENING PARTIAL KNEE. PAIN. DOI: (B)(6) 2018, DOR: (B)(6) 2022, UNKNOWN KNEE.
Patient problems: Pain
MAUDE report 13343182 ↗InjuryAug 18, 2020Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT WAS DUE TO NATURAL PROGRESSION AFTER 20 YEARS INSITU. THE PATELLA WAS NATIVE AND NO IMPLANT WAS REMOVED DURING REVISION. THERE WAS ALSO NO ALLEGATION AGAINST THE ALL POLY TIBIA.
Patient problems: No Code Available; Pain
MAUDE report 10420718 ↗InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN. DOI: (B)(6) 2013; DOR: (B)(6) 2019; RIGHT KNEE.
Patient problems: No Code Available; Pain
MAUDE report 9147240 ↗InjuryNov 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryNov 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond
THE PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED.
Patient problems: No Information
MAUDE report 7005332 ↗
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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