SIGMA 96-0087Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295232544), received between Sep 8, 2017 and Sep 12, 2024 — classified as 7 injuries, 1 malfunction.

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

8 other recalls cover devices cleared under the same FDA submission (K241000, K952830); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  ADDITIONAL INFORMATION WAS RECEIVED: CAN YOU PLEASE CONFIRM WHETHER THE PREVIOUS REVISION (2016) WAS FOR DEPUY PRODUCTS? IF SO, WHAT WAS THE REASON FOR THE REVISION AND WHAT COMPONENTS WERE REMOVED? YES FOR DEPUY PRODUCTS. REMOVED DUE TO LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 20199060 ↗
• 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

  ADDITIONAL INFORMATION RECEIVED: A. IT WAS INDICATED THAT THERE WAS LOOSENING. ON WHAT INTERFACE DID THE LOOSENING OCCURRED? CEMENT BONE. B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. C. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? RIGHT. D. WAS THERE ANY ALLEGATION AGAINST THE TIBIAL COMPONENT? NO. E. CAN YOU CONFIRM IF DEPUY CEMENT WAS USED DURING THE PRIMARY SURGERY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS OF THE CEMENT. QUANTITY OF THE DEPUY CEMENT USED. NO.

  Patient problems: Insufficient Information

  MAUDE report 19527571 ↗
• InjuryApr 13, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE TIBIAL TRAY AT THE BONE TO CEMENT INTERFACE AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. TWO DEPUY CEMENTS WERE USED. IMPLANTS WERE REMOVED AND INSERTION OF ANTIBIOTIC SPACER WAS PERFORMED. DOI: (B)(6) 2015. DOR: (B)(6)2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 14103945 ↗
• InjuryOct 28, 2020Migration; Migration

  REVISED DUE TO SUBSIDENCE AND THE PATIENT¿S ANATOMY. THE INITIAL REVISION WAS PERFORMED IN (B)(6) OF 2016.

  Patient problems: No Code Available

  MAUDE report 10748303 ↗
• MalfunctionSep 25, 2019Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE THERE WAS A DEFICIENCY WITH THE PACKAGING OF THE IMPLANT. THE IMPLANTS INNER PACKAGING (THE STERILE PACKAGE WITH PULL AWAY PAPER TOP) THAT WAS ALREADY TORN PARTIALLY ALMOST AS THOUGH. THE ADHESIVE HOLDING THE WHITE PAPER TO THE PLASTIC PACKAGE HAD FAILED. THEY ENDED UP NOT USING THE IMPLANT SINCE IT WAS COMPRISED.

  Patient problems: Not Applicable

  MAUDE report 9116280 ↗
• 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 8982800 ↗
• InjuryAug 7, 2018Loose or Intermittent Connection; Naturally Worn; Loose or Intermittent Connection; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS METALLOSIS AND LOOSENING OF THE STEM BOLT AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT POLY SWAP SINCE DOING THE REVISION. DOI: (B)(6) 2001; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Tissue Damage

  MAUDE report 7756934 ↗
• InjurySep 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6852397 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K952830. One submission often covers many models, so check the product and lot details in each record.

• Z-2949-2018 · Jul 18, 2018 · Terminated
  P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
• Z-0399-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527.
• Z-0401-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551.
• Z-0400-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544.
• Z-0397-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522.
• Z-0398-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0523.
• Z-0396-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521.
• Z-1369-04 · Dec 22, 2003 · Terminated
  P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703