SIGMA 1024-03-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295001652), received between Jan 19, 2021 and Jan 19, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2021Naturally Worn; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE PATELLOFEMORAL JOINT REPLACEMENT. DATE OF IMPLANTATION: (B)(6) 2009. DATE OF REVISION: (B)(6) 2020. (LEFT KNEE). TREATMENT: FEMORAL AND PATELLAR COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 11193097 ↗

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