P.F.C. SIGMA 96-0830Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295234135), received between Sep 10, 2019 and Jun 13, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jul 18, 2018Class IITerminated

   This unit may be missing the screw/collet Assembly

   Z-2949-2018 · Root cause: Employee error · Recall details · FDA record ↗

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.

• InjuryJun 13, 2024Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LOOSENING OF RIGHT FEMUR TC3 SIGMA. CHANGED FOR AN LPS. TIBIA WAS WELL ADJUSTED IN PLACE. DOI:(B)(6) 2008.

  Patient problems: Insufficient Information

  MAUDE report 19527572 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR FAILED REVISION RIGHT TOTAL KNEE, DUE TO ASEPTIC LOOSENING. DOI: (B)(6) 2006. DOR #1: (B)(6) 2010. DOR #2: (B)(6) 2019 (RIGHT KNEE).

  Patient problems: Foreign Body Reaction; Injury; Joint Disorder; No Code Available; Pain

  MAUDE report 8982811 ↗