SIGMA 96-0081Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295232483), received between Nov 30, 2017 and Dec 14, 2022 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TOTAL KNEE EXPLANT WAS PERFORMED DUE TO KNEE JOINT INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014, DOR: (B)(6) 2022, AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15983808 ↗
• InjuryMar 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED LEFT KNEE. EXTRACTION OF COMPONENTS AND INSERTION OF ANTIBIOTIC SPACER WERE DONE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 13925419 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO LOOSENING REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12719404 ↗
• InjuryOct 22, 2019Fracture; Fracture

  WE RECEIVED A USER REPORT FROM (B)(6) FOR A PATIENT BORN (B)(6). FRACTURE OF THE FEMORAL ANCHORAGE STEM IN REVISION ENDOPROSTHESIS. FRACTURE AT THE SCREW ANCHORAGE AT THE TRANSITION INTRAMEDULLARY STALK/; FEMORAL COMPONENT 3 YEARS AFTER IMPLANTATION.

  Patient problems: No Code Available

  MAUDE report 9218510 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATELLA TENDON WAS REPAIRED AND POLY SWAP WAS DONE. DOI: (B)(6) 2019, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8950444 ↗
• MalfunctionApr 2, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  WE WERE OPERATING A TOTAL KNEE REPLACEMENT. WHEN ALL IMPLANTS SIZES WERE DECIDED AND OPENED WE REALIZED THAT OUR FEMORAL COMPONENT WAS DIRTY (STERILE ONE).

  Patient problems: Not Applicable

  MAUDE report 8473573 ↗
• InjuryFeb 11, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE SURGEON THAT THE PATIENT WAS HAVING ANTERIOR KNEE PAIN THE COULD HAVE BEEN CAUSED BY THE FEMUR BEING INTERNALLY ROTATED AND SUBSEQUENT POOR PATELLA TRACKING. THE SURGEON REMOVED THE FEMORAL COMPONENT AND REPLACED WITH A NEW TC3 FEMUR, CORRECTING THE ROTATION AND MOVING THE JOINT LINE MORE DISTILL WITH THICKER DISTAL AUGMENTS. A NEW INSERT WAS IMPLANTED. DOI: (B)(6) 2017; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8326644 ↗
• InjuryDec 10, 2018Noise, Audible; Noise, Audible

  PATIENT WAS REVISED DUE TO PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8146630 ↗
• MalfunctionNov 28, 2018Material Discolored; Material Discolored

  IT WAS REPORTED THAT THERE IS STAINING/DISCOLORATION ON THE FEMORAL KNEE IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8110792 ↗
• InjuryOct 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS FALL, PAIN AND LOOSENING OF THE FEMUR TO FEMORAL COMPONENT AND BOLT TO FEMORAL ADAPTOR AT THE BONE TO CEMENT AND CEMENT TO IMPLANT.

  Patient problems: Not Applicable; Pain

  MAUDE report 7940125 ↗
• InjuryNov 30, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT INITIATED COMPLAINT; MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED FOR TIBIAL MALPOSITIONING, POLY WEAR, METALLOSIS, AND FEMORAL LOOSENING AT AN UNKNOWN INTERFACE/CEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7071413 ↗

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-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-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-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-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-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-1369-04 · Dec 22, 2003 · Terminated
  P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703