SIGMA 1024-52-200Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL TRAY UNICONDYLAR METAL BACKED SIZE 2 RM/LL · Class 2 · Implant
All models of SIGMA (380)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295002383), received between Jul 27, 2017 and Mar 6, 2026 — classified as 8 injuries.
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 Problem4
- Loss of or Failure to Bond2
- Insufficient Device Problem Information1
- Migration1
Patient problems
- Pain4
- No Code Available3
- Bone Fracture(s)1
- Discomfort1
- Fall1
- Insufficient Information1
- Loss of Range of Motion1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT UNI COMPARTMENT MEDIAL IMPLANTS REMOVED BECAUSE OF TIBIA BASE PLATE LOOSENING AT AN UNKNOWN INTERFACE AND A PRIMARY TOTAL KNEE WAS PERFORMED. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 24536473 ↗InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REVISED UNI TO TOTAL KNEE DUE TO TIBIA FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Bone Fracture(s)
MAUDE report 23559588 ↗InjuryJul 27, 2022Loss of or Failure to Bond; Loss of or Failure to Bond
REMOVAL DUE TO SORE PROSTHESIS AND PARTIAL MOBILIZATION OF THE TIBIAL COMPONENT. REASON THE DEVICE WAS USED: RIGHT KNEE MEDIAL COMPARTMENT PROSTHETIC REPLACEMENT FOR MEDIAL PRIMARY OSTEOARTHRITIS. DOI: (B)(6) 2020. DOR: (B)(6) 2022; RIGHT KNEE.
Patient problems: Discomfort; Loss of Range of Motion
MAUDE report 15112907 ↗InjurySep 20, 2021Migration; Migration
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO EXTENDED TIME OF SURGERY. THE FEMUR AND INSERT WERE WELL FIXED BUT EXTRACTED TO GO COVERT TO A TOTAL KNEE.
Patient problems: Fall
MAUDE report 12496872 ↗InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DUE TO INCREASED PAIN, THE PATIENT'S UNI KNEE WAS CONVERTED TO A TOTAL. DOI: (B)(6) 2017. DOR: (B)(6) 2020; RIGHT KNEE.
Patient problems: No Code Available; Pain
MAUDE report 9866598 ↗InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.
Patient problems: No Code Available; Pain
MAUDE report 9324141 ↗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 9147232 ↗InjuryJul 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
Other PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- R3 71363077Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER461 reports
- NA 71364009Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER174 reports
- JOURNEY 74012415Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012416Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012414Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER129 reports
- GENESIS II 71440194Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER114 reports
- GENESIS II 71440842Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER113 reports
- JOURNEY 74018901Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER106 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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