P.F.C. SIGMA 96-0770Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295233893), received between Feb 28, 2018 and Aug 15, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Disassembly” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2024Fracture; Fracture

  RADIOGRAPHS OF A PATIENT WHO UNDERWENT REVISION TKR 3 YEARS BACK. AT PRESENT SHE PRESENTED A FAILED IMPLANT WITH A BOLT AND STEM JUNCTION. ITS SEEMS TO BE BROKEN.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Joint Laxity; Muscular Rigidity; Pain; Unspecified Tissue Injury

  MAUDE report 19989897 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE 1ST CLEANING OF THE AFFECTED AREA DUE TO INFECTION AFTER PRIMARY SURGERY. THIS PC REPORTS A SECOND CLEANING OF THE AFFECTED AREA AND REVISION OF THE IMPLANT AFTER THE FIRST CLEANING OF THE AFFECTED AREA. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY. AT THE END OF 2023 (DATE UNKNOWN) BECAUSE INFECTION WAS SUSPECTED, THE PATIENT WAS TREATED FOR CLEANING OF THE AFFECTED AREA. ON AN UNKNOWN DATE, THE MCL (MEDIAL COLLATERAL LIGAMENT) WAS CONFIRMED TO BE OPEN. AND THE PATIENT ORIGINALLY HAD MALIGNANT RA. THEREFORE, ON (B)(6) , THE AFFECTED AREA WAS CLEANED, AND THE IMPLANTS WERE FINALLY REMOVED AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 18978486 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. IT IS INDICATED THE PATIENT WAS EXPERIENCING PAIN PRIOR TO REVISION ON (B)(6) 2019. ALSO, THE SURGEON NOTED THE PATIENT EXPERIENCED EXPECTED ACUTE BLOOD LOSS ANEMIA POST-OPERATIVELY AND RECEIVED TWO UNITS OF PACKED RED BLOOD CELLS TO ADDRESS THE ISSUE.

  Patient problems: Foreign Body Reaction; Injury; Joint Disorder; No Code Available; Pain

  MAUDE report 8982805 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY PERFORMED ON (B)(6) 2018. IT WAS REPORTED THAT THE SURGEON RECOGNIZED THAT INFECTION ON THE PATIENT¿S KNEE ON (B)(6) 2018. SINCE THE SURGEON COULD NOT CONTROL THE INFECTION, IMPLANTS WERE EXPLANTED FROM THE PATIENT'S KNEE JOINT DUE TO POSTOPERATIVE INFECTION, AND CEMENT SPACER WAS PLACED IN THE PATIENT'S KNEE JOINT FOR TREATMENT THE KNEE JOINT INFECTION ON (B)(6) 2018. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 7868604 ↗
• InjuryFeb 28, 2018Disassembly; Disassembly

  IT WAS STATED A TOTAL KNEE REVISION PERFORMED ON (B)(6) 2018. THE SIGMA 0 MM BOLT CAME LOOSE AT SOME POINT AS A RESULT OF THE ONE PIECE 7 DEGREE FEMORAL STEM BREAKING. REVISED TO A LPS DISTAL FEMORAL REPLACEMENT. LOOSENING OCCURRED FROM BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER COMPETITOR. DOI: 2009; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7302815 ↗

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