SIGMA 1024-03-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295001614), received between Jan 31, 2022 and Feb 9, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K061648, K233980); they may or may not involve this specific model.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2022Loss of or Failure to Bond; Device Dislodged or Dislocated; Loss of or Failure to Bond; Device Dislodged or Dislocated

  PATIENT UNDERWENT PRIMARY PATELLA FEMORAL JOINT REPLACEMENT IN (B)(6) 2015. (B)(6) HOSPITAL. PATIENT HAS COMPLAINED THAT THIS PF JOINT HAS NEVER FELT GOOD AND HAS BEEN PAINFUL SINCE TIME INDEX SURGERY. A DECISION WAS MADE TO REVISE THE PF JOINT TO A TOTAL KNEE REPLACEMENT. ON OPENING THE KNEE, THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE. PROGRESSION ON DISEASE WAS ALSO FOUND IN THE OTHER CONDYLES. THE FEMORAL COMPONENT AS WELL AS THE INSERT PATELLA COMPONENT WAS REMOVED AND A TOTAL JOINT I PLANTED. ((B)(6) HOSPITAL, (B)(6) 2022). DEPUY CEMENT WAS NOT UTILISED. THE FEMORAL COMPONENT WAS LOOSE AT THE CEMENT BONE INTERFACE WITH THE COMPONENT COMING LOOSE WITH THE CEMENT STILL ADHERED TO THE UNDERSIDE. DOI: (B)(6) 2015; DOR: (B)(6) 2022; UNKNOWN KNEE.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 13498070 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT TKA ABOUT 6 YEARS AGO. REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF PAIN. ON OPENING THE KNEE, THE PF JOINT WAS FOUND TO BE WELL FIXED (BOTH THE FEMORAL AND THE PATELLA COMPONENT). ARTHRITIC CHANGES WERE NOTED IN THE OTHER COMPARTMENTS.

  Patient problems: Pain

  MAUDE report 13399870 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061648, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1219-2018 · Dec 21, 2017 · Terminated
  (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GT