SIGMA 97-0470Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295250661), received between Aug 3, 2018 and Feb 25, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT KNEE REVISION DUE TO INFECTION OF JOINT. A TIBIAL INSERT WAS CHANGED AS A RESULT.

  Patient problems: Unspecified Infection

  MAUDE report 21462414 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO THE REVISION WAS SUSPICION OF INFECTION. ORIGINAL SURGERY WAS DONE IN 2013. THE SURGEON REMOVED PART LISTED BELOW AND REPLACED WITH A NEW POLY INSERT. I AND D POLY SWAP. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: YEAR 2013. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16103271 ↗
• InjuryAug 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS ANTERIOR KNEE PAIN. PATIENT WAS BROUGHT BACK FOR A POLY EXCHANGE AND PATELLA REVISION. PATELLA BONE WAS RESECTED AND REVISED TO A NEW PATELLA. DOI: 2008; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7748099 ↗