SIGMA 96-0002Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295231943), received between Jan 31, 2018 and Apr 18, 2023 — classified as 8 injuries.

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, K943462); 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.

• InjuryApr 18, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2002, THE PRIMARY SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE REVISION SURGERY WAS PREFORMED ON (B)(6) 2023, TO REMOVE THE FEMORAL COMPONENT, TREY AND INSERT. THE PATELLA WAS RESERVED. TRIATHLON KNEE FROM STRYKER WAS PLACED. (SIZE AND TYPE ARE UNKNOWN.) THE SURGEON COMMENTED THAT THE REASON FOR THE REPLACEMENT SURGERY WAS LOOSENING OF THE FEMORAL COMPONENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16761198 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER LEFT KNEE REPLACED IN (B)(6). THE EXACT DATE IS UNKNOWN NOR WAS THERE AN OPERATIVE REPORT AVAILABLE. SHE CAME BECAUSE OF STABILITY AND PAIN ISSUES IN HER LEFT KNEE. X-RAYS INCITED THAT THE CONSTRUCT WAS A DEPUY SIGMA CR RP TOTAL KNEE CONSTRUCT. THE SURGEON REVISED HER LEFT KNEE AND FOUND THAT THE POLYETHYLENE RP INSERT WAS WORN OUT POSTERIOR LATERAL WHICH MAY HAVE RESULTED IN AN UNBALANCED KNEE. A SIZE 2 LEFT CR SIGMA FEMUR AND A SZ 2 X 10 CVD RP INSERT WAS EXPLANTED. A NEW SZ 2 PS FEMUR WITH A STEM EXTENSION WAS IMPLANTED WITH A SZ 2 X 10MM PS INSERT. THE LOT NUMBER INFORMATION WAS UNABLE TO BE RECORDED BECAUSE OF BONE CEMENT IN THE BACK SIDE OF FEMUR. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16246652 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE 27 JAN 2020. MEDICAL RECORDS WERE REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY AND SYNOVITIS. THE SURGEON NOTED MINIMAL TIBIAL INSERT WEAR. THE TIBIAL INSERT WAS THE ONLY COMPONENT REVISED. THE TIBIAL TRAY, FEMORAL COMPONENT, AND PATELLAR COMPONENT WERE WELL-FIXED AND RETAINED. DOI: (B)(6) 2015. DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9637407 ↗
• InjuryAug 12, 2019Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PARTIAL TEAR OF PATELLAR TENDON WITH GOOD. FUNCTIONING : EXTENSOR MECHANISM INSUFFICIENCY. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT: (B)(6) 2019, (LEFT KNEE).

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Loss of Range of Motion; Muscular Rigidity; No Code Available; Pain; Scar Tissue; Swelling; Tissue Damage; Weakness

  MAUDE report 8885320 ↗
• InjuryMay 31, 2019Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  PATIENT WAS REVISED TO ADDRESS MALPOSITIONED FEMORAL COMPONENT AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2018; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8658267 ↗
• InjuryOct 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 8009607 ↗
• InjuryJul 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PRIMARY SURGERY WAS PERFORMED TO IMPLANT THE IMPLANTS TO THE PATIENT¿S LEFT KNEE JOINT (DATE OF PRIMARY SURGERY WAS UNKNOWN). THE PATIENT COMPLAINED THE PAIN (ABOUT A YEAR AGO), SO THAT THE SURGEON FOUND THE LOOSENING OF THE KNEE IMPLANTS. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 DUE TO THE LOOSENING. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Not Applicable; Pain

  MAUDE report 7706409 ↗
• InjuryJan 31, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS FROM DEPUY. (B)(6) 2011; (B)(6) 2018; LEFT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7230343 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K943462. One submission often covers many models, so check the product and lot details in each record.

• Z-1077-2014 · Dec 9, 2013 · Terminated
  PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
• Z-1686-2009 · May 7, 2009 · Terminated
  DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. The devic
• Z-0403-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 8 mm, 71mm M/L, 47 mm A/P, UHMWPE, sterile; Product Code/ REF 96-0640.
• Z-0407-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 5, 15mm, 83mm M/L, 55mm A/P, UHMWPE, sterile; Product Code/REF 96-0663.
• Z-0405-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650.
• Z-0404-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 10mm, 71mm M/L, 47mm A/P, UHMWPE, sterile; Product Code/REF 96-0641.
• Z-0402-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 2.5, 8 mm, 67mm M/L, 45 mm A/P, UHMWPE, 2.5, sterile; Product Code/REF 96-0630.
• Z-0406-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651.