SIGMA 1024-04-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295001676), received between Mar 22, 2019 and Jan 30, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Audible Prompt/Feedback Problem” (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.

• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE CLAIM RECORD RECEIVED. CLAIM RECORD ALLEGES FAILED PATELLOFEMORAL ARTHROPLASTY. DEPUY CEMENT WAS USED. PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A RIGHT KNEE PATELLA FEMORAL ARTHROPLASTY DUE TO PATELLAFEMORAL ARTHRITIS. REVISION OPERATIVE NOTES (B)(6) 2018 INDICATE THE PATIENT RECEIVED A RIGHT PATELLA FEMORAL KNEE REVISION WITH IMPLANTATION OF COMPETITOR RIGHT TOTAL KNEE DUE TO FAILED PATELLA FEMORAL KNEE ARTHROPLASTY. UPON ENTERING THE JOINT, HYPERTROPHIC SCARRING IS ENCOUNTERED ALONG WITH OSTEOPHYTES ALONG THE FEMORAL COMPONENT, SCARING AND OSTEOPHYTES REMOVED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6). DOR: (B)(6). RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9647340 ↗
• InjuryMar 22, 2019Noise, Audible; Audible Prompt/Feedback Problem; Noise, Audible; Audible Prompt/Feedback Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A TROCHELAR IMPLANT. DOI: (B)(6) 2015; DOR: NOT REPORTED, RIGHT KNEE.

  Patient problems: Discomfort; Pain; Swelling

  MAUDE report 8443418 ↗

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