SIGMA 96-0088Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10603295232551), received between Jun 23, 2017 and Apr 22, 2026 — classified as 43 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE UNKNOWN INTERFACE BECAUSE OF A BROKEN CONDYLE. CEMENT MANUFACTURER WAS UNKNOWN. IMPLANT WAS PUT IN ON (B)(6) 2019. THE PATIENT WAS COMPLAINING OF PAIN AND THE BONE SCAN SHOWED LOOSENING OF THE FEMORAL IMPLANT. WHEN THEY GOT IN THERE, THE IMPLANT WAS LOOSE BECAUSE THERE WAS A FRACTURE OF THE LATERAL FEMORAL CONDYLE AFTER SEVERAL FALLS. NO INFECTION WAS PRESENT SO THEY WENT TO A PROM HINGE. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Limb Fracture; Pain

  MAUDE report 24956958 ↗
• InjuryMar 6, 2026Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED PROVIDING ANSWERS FROM THE FOLLOWING QUESTIONS: CAN YOU PLEASE CONFIRM THE PRODUCT CODE OF THE REPORTED DEVICE? - I CAN CONFIRM THAT PRODUCT CODES PROVIDED IN THE EMAIL ARE CORRECT. WHAT IS THE EXACT ALLEGATION OF THE REPORTED PRODUCT? - MINIMAL LOOSENING ON THE TIBIAL COMPONENT. MOSTLY SOFT TISSUE INSTABILITY. ON WHAT INTERFACE DID THE LOOSENING OCCURRED? - TIBIAL BASE PLATE AND TIBIA.

  Patient problems: Joint Laxity

  MAUDE report 24533335 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL RIGHT KNEE. SURGEON CONVERTED FROM A TC3 TO DISTAL FEMORAL REPLACEMENT. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21596963 ↗
• InjuryMar 6, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY, 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. A FRACTURE OF THE FEMORAL STEM AND THE CONNECTING SCREW OCCURRED WITHOUT TRAUMA. THE CONNECTING SCREW BETWEEN THE FEMORAL SHIELD AND THE FEMORAL SHAFT IS AFFECTED. THE REVISION WENT SMOOTHLY.

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

  MAUDE report 21536910 ↗
• MalfunctionSep 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE MEDICAL RECORD REPORT RECEIVED STATES THAT ON (B)(6) 2024 THE PATIENT IS HAVING A FOLLOW-UP STATUS POST RIGHT TOTAL KNEE ARTHROPLASTY. IT WAS NOTED THAT THE PATIENT HAD AN INJURY WHEN THEY STEPPED OUT OF A CAR AND FELT A POP, WITH PAIN. THE PATIENT FEELS THAT THE KNEE FEELS LIKE A SQUEEZING SUBLUXATION. RADIOGRAPHS NOTE THAT THE COMPONENTS APPEAR STABLE AND THE PATELLA TRACKS CENTRALLY WITH NO TILT OR SUBLUXATION. THE CLINICAL IMPRESSION IS FOR PATELLAR CLUNK, STATUS POST TOTAL KNEE ARTHROPLASTY. THE PLAN IS TO WAIT AT THIS TIME.

  Patient problems: Insufficient Information; Pain; Unspecified Musculoskeletal problem

  MAUDE report 20225093 ↗
• InjuryMay 7, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED: PLEASE CONFIRM WHAT IMPLANTS WERE MISPOSITIONED. ¿ FEMORAL COMPONENT AND TIBIAL TRAY. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO, DUE TO THE MISPOSITIONING OF THE IMPLANTS. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, ALL CORRECT SIZING. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, REPORTED AS OKAY. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Joint Laxity

  MAUDE report 19261604 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. NO DELAY. DOI- (B)(6) 2020. DOR- (B)(6) 2023. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18118940 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2023, (RIGHT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 17539869 ↗
• InjuryAug 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD PRIMARY TKR AND HAS HAD ONGOING ISSUES SINCE WITH PAIN, SWELLING AND LOOSENING. PATIENT HAD A PARTIAL REVISION FOR PAIN AND LOOSENING. PATIENT PRESENTED AGAIN WITH PAIN AND BONE SCANS SUGGESTING LOOSENING. REVISED ENTIRE CONSTRUCT. PRESENTED AGAIN WITH PAIN. BONE SCAN SUGGESTED LOOSENING SO REVISED TO ATTUNE REVISION WITH STEMS AND SLEEVES. IMPLANTS WEREN'T GROSSLY LOOSE AND REQUIRED SOME WORK (FLEXIBLE OSTEOTOMES AROUND METAPHYSEAL SLEEVES AND SLAP HAMMER ATTACHMENTS) TO REMOVE. DOI: (B)(6) 2017. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17459434 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TORN MCL AND PCL AND INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: THICKER IMPLANT REQUIRED WITH AUGMENTATION. DEPUY PRODUCTS USED (NO REVISION COMPLETED).

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17224173 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16214055 ↗
• InjuryNov 30, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT "W T (PHONE NUMBER (B)(6) LEFT A VOICEMAIL FOR ONE OF MY TEAM MEMBER. HE DIDN¿T LEAVE ANY INFORMATION EXCEPT THAT HE HAD A KNEE REPLACEMENT TWICE. HE EXPECTS A CALL BACK. COULD YOUR TEAM REACH OUT TO HIM?"

  Patient problems: Adhesion(s); Inflammation; Joint Laxity; Pain; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 15885812 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO TC3 RP W/O ROM, CONVERTED TO NOILES HINGE FOR LIGAMENTOUS STABILITY. COMPETITOR BONE CEMENT WAS USED. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 15845618 ↗
• MalfunctionJul 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT STATED THAT "I ATTACH DETAILS OF THE IMPLANT ELEMENTS WHERE I AM SEEKING THE DATE OF MANUFACTURE - OR, MORE IMPORTANTLY, TO DISCOVER WHICH GENERATION OF SIGMA PFC IMPLANTS WERE USED. THIS IS WITH REFERENCE TO ADAPTATIONS THAT WERE MADE FURTHER TO THE DISCOVERY THAT EARLIER VERSIONS WERE IMPLICATED IN CASES OF PATELLA CLUNK. IT IS MY UNDERSTANDING THAT MORE RECENT DESIGNS REMOVED THE ISSUES ASSOCIATED WITH THE FORMATION OF PATELLA CLUNK. ARE THE IMPLANT DETAILS OUTLINED IN RED THE MOST UP-TO-DATE GENERATION? I FEAR THAT I AM UNABLE TO SUPPLY AN ACCOUNT NUMBER OR UCN AS THIS IS A PERSONAL ENQUIRY. I WOULD, HOWEVER, BE MORE THAN GRATEFUL IF YOU WERE ABLE TO SUPPLY ME WITH THIS INFORMATION. I WILL NOT BORE YOU WITH TOO MUCH DETAIL HERE, BUT THIS INFORMATION HAS THE POTENTIAL TO BE EXTREMELY IMPORTANT FOR ME AS FURTHER SURGERY IS CONTEMPLATED."

  Patient problems: Insufficient Information

  MAUDE report 15029419 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS BROKEN ADAPTOR AND BOLT IN TC3 FEMORAL COMPONENT. DOI: (B)(6) 2013, DOR: (B)(6) 2022, UNKNOWN KNEE.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Fall; Pain

  MAUDE report 13576403 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED ON RIGHT KNEE SECONDARY TO SEVERAL DISLOCATIONS. SURGEON DISCOVERED THE TIBIAL INSERT WAS ROTATED 180 DEGREES POSTERIORLY. SURGEON NOTED LIGAMENTOUS DEFICIENCIES AND ELECTED TO CONVERT THE KNEE CONSTRUCT TO A HINGED FEMORAL COMPONENT. THE FEMORAL HINGE COMPONENT AND TIBIAL INSERT WERE EXCHANGED. THE INDEX FEMORAL SLEEVE AND STEM, THE TIBIAL CONSTRUCT, AND THE PATELLA WERE KEPT. SURGEON STATED HE DID NOT THINK THE COMPONENTS FAILED TO MEET EXPECTATIONS.

  Patient problems: Joint Laxity

  MAUDE report 13559680 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF PAIN AND INSTABILITY. IN SURGERY SURGEON FOUND FEMUR TO BE LOOSE, BUT TIBIA SOLID. A HINGED FEMUR ALONG WITH SLEEVE AND STEM AND THICKER POLY WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2022. RIGHT FEMUR.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13446169 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION TKA AFTER AN INFECTION WITH A TC3 IMPLANTS PLACED ON (B)(6) 2020. SHE WAS RETURNED TO SURGERY TODAY DUE TO A REPEAT KNEE INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. ADDITIONAL PART USED AND REMOVED, NOT RETURNED 960784/J38U33 960861/HK5168 962343/HU0956 DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (RIGHT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 13043323 ↗
• InjuryOct 29, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  Patient problems: Fall; Joint Laxity

  MAUDE report 12719679 ↗
• InjurySep 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A REV KNEE DONE IN 2017 BY THE SAME DR AT THE SAME HOSPITAL FOR THE SAME PROBLEM. THE FEMORAL ADAPTOR BOLT AND ADAPTOR WAS BROKEN LEAVING THE FEMORAL COMPONENT DECOUPLED FROM THE SLEEVE STEM CONSTRUCT. THE FEMORAL COMPONENT, BROKEN BOLT AND TIBIAL INSERT WERE REMOVED. WE TURNED OUR ATTENTION TO THE ADAPTOR THAT WAS FIXED TO THE SLEEVE, AFTER MANUY ATTEMPTS TO BREAK THE TAPER BETWEEN THE ADAPTOR AND THE SLEEVE WE WERE UNSUCCESSFUL. THE STEM, SLEEVE AND REMAIN PIECE OF THE ADAPTOR BOLT WERE REMOVED AND A DISTAL FEMORAL REPLACEMENT WAS PREFORMED. FEMORAL SLEEVE AND STEM WERE FROM ORIGINAL SURGERY IN 2017, I DO NOT HAVE SIZES OR LOT NUMBERS FOR THESE IMPLANTS. DOI: (B)(6) 2017 , DOR: (B)(6) 2021, (RIGHT KNEE).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12438489 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED THE KNEE BECAUSE THE PATIENT COMPLAINED OF SHIN PAIN. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2019; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12414058 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAINFUL RIGHT TOTAL KNEE WITH CREPITANS, ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2010 (COMPETITOR KNEE SYSTEM). DATE OF REVISION #1: (B)(6) 2010 (REVISION OF COMPETITOR FEMUR, TIBIAL TRAY, INSERT - COMPETITOR PATELLA RETAINED). DATE OF EVENT (ONSET): (B)(6) 2013, (RIGHT KNEE). TREATMENT: SURGICAL ARTHROTOMY WITH EXCISION OF SCAR TISSUE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12363717 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SIGNIFICANT FLEXION CONTRACTURE BUT INSTABILITY IN FLEXION. TIBIAL COMPONENTS REMOVED ALONG WITH FEMORAL COMPONENTS AND CONVERTED TO DISTAL FEMORAL REPLACEMENT ON EXISTING FEMORAL SLEEVE AND STEM. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity

  MAUDE report 11555042 ↗
• InjuryFeb 26, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO BONE AND CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2018, DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11388399 ↗
• InjuryNov 3, 2020Loss of or Failure to Bond; Loss of Osseointegration; Illegible Information; Loss of or Failure to Bond; Loss of Osseointegration; Illegible Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10782397 ↗

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-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-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