P.F.C. SIGMA 96-0771Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295233909), received between Sep 8, 2017 and Feb 4, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2025Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED DESCRIBES A REVISION PROCEDURE REQUIRING EXTENSIVE DEBRIDEMENT. EXTENSIVE BONE EROSION WAS NOTED ON THE MEDIAL AND LATERAL FEMORAL CONDYLES AS WELL AS ALONG THE MEDIAL TIBIAL PLATEAU REQUIRING BONE GRAFTING TO CORRECT. GRANULATION TISSUE INDICATIVE OF LOOSENING WAS NOTED. THE FEMORAL AND TIBIAL SIDES WERE NOTED TO BE LOOSE - INTERFACE NOT IDENTIFIED. THE PATELLA WAS REMOVED AND UNDERNEATH SMALL CYSTS WERE IDENTIFIED AND REMOVED BEFORE REPLACING. THIS IS THE RIGHT SIDE. THE DATE OF OPERATION FOR THE FIRST IMPLANTATION WAS ON (B)(6) 2008, WITHOUT COMPLICATIONS. THE REVISION WENT SMOOTHLY. THE CONNECTING SCREW BETWEEN THE FEMORAL SHIELD AND THE FEMORAL SHAFT IS AFFECTED.

  Patient problems: Bone Notching; Insufficient Information; Pocket Erosion; Unspecified Tissue Injury

  MAUDE report 21302617 ↗
• InjuryJun 13, 2023Adverse 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 CLEANING AND RE-REVISION SURGERY AFTER THE CONFIRMATION OF INFECTION. THIS PC REPORTS THE PAIN AND INFECTION AFTER THE REVISION SURGERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED. IT IS ALSO UNKNOWN WHETHER THE IMPLANTS USED IN THE PRIMARY SURGERY ARE JJ PRODUCTS OR NOT. ON (B)(6) 2022, THE REVISION SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. THE REASON FOR THE REVISION IS UNKNOWN. AFTER THE REVISION SURGERY, ON (B)(6), 2023, THE PATIENT CAME TO THE HOSPITAL COMPLAINING OF THE SUDDEN KNEE PAIN, AND THE INFECTION WAS CONFIRMED. NO FURTHER INFORMATION IS AVAILABLE. DOI; (B)(6) 2022; DOR: (B)(6) 2023; AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17116842 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE SWELLING/HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2016. DATE OF EVENT: (B)(6) 2022 (LEFT KNEE). TREATMENT: ASPIRATED FOR BLOOD AND MILD CLOUDINESS; SENT FOR SYNOVASURE AND CAME BACK NEGATIVE FOR BOTH AEROBIC AND ANAEROBIC ORGANISM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 16149545 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE PRIMARY SURGERY. THIS PC REPORTS ABOUT THE REMOVAL SURGERY DUE TO INFECTION. AFTER THE REVISION TKA SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL SURGERY ON (B)(6) 2021 BECAUSE INFECTION OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12882794 ↗
• InjuryOct 29, 2020Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  REVISION ON (B)(6) 2020 OF PREVIOUSLY REVISED KNEE TO TREAT BONE LOSS SECONDARY TO ASEPTIC FEMORAL IMPLANT LOOSENING. AN ATTUNE REVISION WAS USED TO REVISE A TC3. ORIGINAL REVISION SURGERY (TC3) WAS CONDUCTED ON (B)(6) 2009. REASON FOR RE-REVISION WAS FEMORAL LOOSENING (FEMUR + STEM CONSTRUCT). THE ORIGINAL MBT REVISION WAS STILL WELL FIXED SO DIDN'T REQUIRE REMOVAL/REPLACEMENT. TC3 FEMUR + STEM WAS REMOVED. INSERT WAS REMOVED. ATTUNE REVISION FEMUR, SLEEVE AND STEM IMPLANTED. ATTUNE REVISION CRS INSERT IMPLANTED INTO ORIGINAL MBT TRAY (NOT INDICATED).

  Patient problems: Inadequate Osseointegration; Injury; No Code Available

  MAUDE report 10757978 ↗
• InjurySep 21, 2020Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REASON FOR SURGERY WAS THE SINKING OF THE TIBIAL SIDE AND THEN OCCURRING THE FRACTURE. BONE FRACTURE WAS CONFIRMED.

  Patient problems: No Code Available

  MAUDE report 10562317 ↗
• InjuryDec 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS FEMORAL COMPONENT LOOSENING AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. THE BOLT HOLDING ADAPTER AND STEM BECAME LOOSE. MICROMOTION CAUSED METALLOSIS. DOI: UNKNOWN; DOR: (B)(6) 2019; LT KNEE.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9451103 ↗
• InjuryOct 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REPORTING A REVISION OF SIGMA TC3 FIXED BEARING KNEE IMPLANTS AT ROYAL LANCASTER INFIRMARY. ALL COMPONENTS WERE REMOVED WITHOUT DIFFICULTY. IT SHOULD BE NOTED THAT UPON REMOVAL OF THE FEMORAL COMPONENT, IT WAS OBSERVED THAT THE FEMORAL COMPONENT AND THE FEMORAL ADAPTOR WERE SLIGHTLY LOOSE AND CAN BE ROTATED ¿ QUESTIONING WHETHER INSUFFICIENT TORQUE WAS USED UPON INITIAL IMPLANT PREPARATION BY SURGICAL TEAM. THE DISASSOCIATION OCCURRED BETWEEN THE BOLT AND THE STEM AS THIS IS A STEM-BOLT CONFIGURATION.

  Patient problems: No Code Available; Pain

  MAUDE report 9180948 ↗
• InjurySep 8, 2017Fracture; Fracture

  DER STATED THAT THE BOLT ATTACHING FEMORAL STEM TO FEMORAL COMPONENT SNAPPED OFF (96-0771). IT WAS ALSO STATED THAT THERE WAS A LOOSENING OCCURRED FROM BONE TO CEMENT INTERFACE. CEMENT IS OF COMPETITOR. SURGEON LEFT TIBIAL COMPONENT AND PATELLA AND REMOVED EVERYTHING ELSE AND PLACED NEW FEMORAL COMPONENT AND INSERT IN.

  Patient problems: No Information

  MAUDE report 6851152 ↗

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-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-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-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