P.F.C. SIGMA 86-4182Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295216445), received between Nov 14, 2017 and Apr 24, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 reports).

7 other recalls cover devices cleared under the same FDA submission (K830927, K961685); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: LOOSE (UNKNOWN COMPONENT OR INTERFACE) AND PAIN.

  Patient problems: Pain

  MAUDE report 19176100 ↗
• InjuryApr 16, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSE OF FEMUR AND PATELLA. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2002. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19117443 ↗
• InjuryMar 24, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO LOOSE TIBIAL COMPONENT, OSTEOLYSIS, AND POLYETHYLENE WEAR. TIBIAL COMPONENT WAS ALSO REVISED.

  Patient problems: Insufficient Information

  MAUDE report 13889661 ↗
• InjurySep 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE LOOSENING INTERFACE WAS BONE TO CEMENT.

  Patient problems: Insufficient Information

  MAUDE report 12481244 ↗
• InjuryMay 5, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE AND BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2003 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11780505 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR REVISION WAS TIBIAL LOOSENING APPEARED TO BE APPARENT ON XRAY AND BONE SCANS (AS PER SURGEON). IMPLANTS REMOVED. CEMENT FRAGMENTS AMD OLD BLOOD FOUND WITHIN THE JOINT SPACE. SAMPLES OF SYNOVIUM TAKEN. IMPINGEMENT APPARENT ON THR POSTERIOR OF THE POLY INSERT POST AND ON THE POSTERIOR POLY INSERT ARTICULATING SURFACE. THERE ARE NO IMAGES OR X RAYS AVAILABLE. SURGEON PROVIDED NO SPECIFIC CAUSE FOR REVISION BY THE END IF THE CASE.

  Patient problems: No Code Available

  MAUDE report 9291691 ↗
• InjuryAug 6, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. PF CR SIGMA FEMUR AND CVD INSERT WERE ALSO REMOVED. A REVISION TC3/MBT CONSTRUCT WAS IMPLANTED. NO FURTHER PATIENT INFORMATION AVAILABLE. DOI: 2000; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8865975 ↗
• InjuryMar 12, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS COMPETITOR. SURGEON REVIEWED CURRENT X-RAYS SUSPECTED LOOSENING AND REVISION WAS DONE. DOI: (B)(6) 2017. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8412969 ↗
• InjuryJan 31, 2019Malposition of Device; Malposition of Device

  PATIENT WAS REVISED TO ADDRESS INSTABILITY AND IMPLANT MALALIGNMENT.

  Patient problems: No Code Available

  MAUDE report 8292552 ↗
• InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8146017 ↗
• InjurySep 7, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE UNKNOWN INTERFACE. COMPETITOR CEMENT WAS USED. IN SURGERY THE FEMORAL AND TIBIAL COMPONENT WERE UNSTABLE/NOT FIXATED. DOI: (B)(6) 2012; DOR: (B)(6) 2018 LEFT SIDE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7854841 ↗
• InjuryJun 26, 2018Fracture; Fracture

  REVISION TOTAL KNEE REPLACEMENT; (B)(6), (B)(6) HOSPITAL (B)(6) 2018. PRIMARY DATE UNKNOWN. 1ST REVISION WAS PERFORMED ON (B)(6) 2014 AFTER A FALL AND PATELLA FRACTURE. THE PATELLA AND TIBIAL LINER WAS REPLACED AT THIS REVISION. I HAVE NOT BEEN ABLE TO ESTABLISH PRIMARY SURGICAL DATE. ON (B)(6) 2018 EXPLORATION OF TOTAL KNEE UNDERTAKEN DUE TO PATIENT PRESENTING WITH KNEE PAIN. ON EXAMINATION OF THE TIBIAL TRAY IT WAS NOTED TO BE LOOSE. THE SURGEON STATED THAT THE PATIENT HAD A FALL IN 2014 WHICH LEAD TO A PATELLA FRACTURE. THE TIBIAL TRAY AND LINER WAS REMOVED AND REPLACED WITH A REVISION MBT TRAY AND CR RP LINER. NO SUPPORTING DOCUMENTATION AVAILABLE. MALE PATIENT INITIALS (B)(6), AGED (B)(6) YEARS, DOB: (B)(6), WEIGHT: (B)(6) KGS.

  Patient problems: Pain

  MAUDE report 7637186 ↗
• InjuryNov 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT AN UNKNOWN INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 7027826 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K830927, K961685. One submission often covers many models, so check the product and lot details in each record.

• Z-0057-2007 · Sep 14, 2006 · Terminated
  Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
• Z-1317-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353.
• Z-1320-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 15.0 mm; Ref 97-0373.
• Z-1315-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 97-0340.
• Z-1316-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352.
• Z-1319-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 10.0 Ref 97-0371.
• Z-1318-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361.