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P.F.C. SIGMARecalls & reported problems across all models

Depuy (Ireland) · 487 models in the FDA device registry

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

Adverse event reports
5,192
Deaths reported
1
Injuries reported
4,327
Recalls
1

We found 487 models of P.F.C. SIGMA by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 5,192 adverse event reports in the FDA's MAUDE database, received between Oct 25, 2016 and Sep 30, 2026 — classified as 1 death, 4,327 injuries, 864 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (467 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 37 reportsDec 2023: 30 reportsJan 2024: 38 reportsFeb 2024: 35 reportsMar 2024: 53 reportsApr 2024: 42 reportsMay 2024: 14 reportsJun 2024: 22 reportsJul 2024: 11 reportsAug 2024: 16 reportsSep 2024: 29 reportsOct 2024: 37 reportsNov 2024: 23 reportsDec 2024: 13 reportsJan 2025: 20 reportsFeb 2025: 19 reportsMar 2025: 21 reportsApr 2025: 12 reportsMay 2025: 23 reportsJun 2025: 27 reportsJul 2025: 28 reportsAug 2025: 12 reportsSep 2025: 6 reportsOct 2025: 14 reportsNov 2025: 22 reportsDec 2025: 32 reportsJan 2026: 16 reportsFeb 2026: 13 reportsMar 2026: 17 reportsApr 2026: 22 reportsMay 2026: 7 reportsJun 2026: 6 reportsJul 2026: 7 reportsAug 2026: 16 reportsSep 2026: 3 reportsOct 2026: 0 reports20242025202653
Last 36 months. The most recent month may be incomplete.

P.F.C. SIGMA recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  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 P.F.C. SIGMA problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2,779
  • Loss of or Failure to Bond467
  • Naturally Worn448
  • Insufficient Device Problem Information309
  • Break300
  • Fracture219
  • Appropriate Device Problem Term/Code Not Available95
  • Device-Device Incompatibility90

Patient problems

  • Pain1,645
  • No Code Available1,374
  • Unspecified Infection1,013
  • Joint Laxity552
  • No Clinical Signs, Symptoms or Conditions387
  • No Consequences Or Impact To Patient375
  • Insufficient Information364
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available267

P.F.C. SIGMA models

487 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

Recent P.F.C. SIGMA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Depuy (Ireland) products

All Depuy (Ireland) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page