SIGMA 1024-55-507Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 5 LM/RL 7MM · 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 10603295501657), received between May 8, 2024 and Oct 23, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT WHEN TRYING TO IMPLANT THE INSERT, IT WOULD NOT ENGAGE THE LOCKING MECHANISM OF THE TRAY. SURGEON CLEARED ANY CEMENT OR BONE NEEDED FOR A CLEAR INSERTION OF THE INSERT. THE INSERT STILL WOULD NOT ENGAGE. THE GROOVE ON THE INSERT SEEMED DAMAGED. OPENED A NEW INSERT AND IMPLANTED THE NEW INSERT WITHOUT ANY ISSUES. DELAY IN SURGERY 10 MINS. NO INJURY TO PATIENT. DOI: (B)(6)2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373896 ↗InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED FOR INFECTION. EXPLANTED THE TIBIAL UNI INSERT AND WASHOUT THE KNEE. PATIENT'S' LEFT KNEE. ORIGINAL DOS WAS (B)(6) 2024 NO DELAY IN SURGERY. NO INJURY TO PATIENT.
Patient problems: Unspecified Infection
MAUDE report 19270191 ↗
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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