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P.F.C. SIGMA 96-0872Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA DISTAL AUGMENT COMBO SIZE 3 16mm RIGHT · Class 3 · Implant

All models of P.F.C. SIGMA (487)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295234357), received between Aug 4, 2023 and Aug 4, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).

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

Device problems

  • Loss of or Failure to Bond2

Patient problems

  • Pain2
  • Swelling/ Edema2

Recent adverse event reports

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

  • InjuryAug 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

    PATIENT HAD PRIMARY TKR (LCS WITH DUOFIX FEMUR) (B)(6) 2008. HAS HAD ONGOING ISSUES SINCE WITH PAIN, SWELLING & LOOSENING. HAD PARTIAL REVISIONS IN (B)(6) 2011 & (B)(6) 2012 FOR PAIN & LOOSENING. PATIENT PRESENTED AGAIN IN 2017 WITH PAIN & BONE SCANS SUGGESTING LOOSENING - REVISED ENTIRE CONSTRUCT TO TC3 WITH MBT SLEEVES & STEMS. PRESENTED AGAIN IN 2023 WITH PAIN. BONE SCAN SUGGESTED LOOSENING SO REVISED TO ATTUNE REVISION WITH STEMS & SLEEVES. IMPLANTS WEREN'T GROSSLY LOOSE AND REQUIRED SOME WORK (FLEXIBLE OSTEOTOMES AROUND METAPHYSEAL SLEEVES & SLAP HAMMER ATTACHMENTS) TO REMOVE. DOI: (B)(6) 2008. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

    Patient problems: Pain; Swelling/ Edema

    MAUDE report 17459976 ↗
  • InjuryAug 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

    PATIENT HAD PRIMARY TKR AND HAS HAD ONGOING ISSUES SINCE WITH PAIN, SWELLING AND LOOSENING. PATIENT HAD A PARTIAL REVISION FOR PAIN AND LOOSENING. PATIENT PRESENTED AGAIN WITH PAIN AND BONE SCANS SUGGESTING LOOSENING. REVISED ENTIRE CONSTRUCT. PRESENTED AGAIN WITH PAIN. BONE SCAN SUGGESTED LOOSENING SO REVISED TO ATTUNE REVISION WITH STEMS AND SLEEVES. IMPLANTS WEREN'T GROSSLY LOOSE AND REQUIRED SOME WORK (FLEXIBLE OSTEOTOMES AROUND METAPHYSEAL SLEEVES AND SLAP HAMMER ATTACHMENTS) TO REMOVE. DOI: (B)(6) 2017. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

    Patient problems: Pain; Swelling/ Edema

    MAUDE report 17459468 ↗

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Sources and updates

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