P.F.C. SIGMA 96-0861Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295234272), received between Dec 15, 2017 and Mar 6, 2025 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 reports).

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 21536914 ↗
• 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 18119093 ↗
• 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 17539856 ↗
• 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.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17224161 ↗
• MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ON 31-JAN-2022, A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH (B)(4)¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE ATTACHED SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS. ON (B)(6) 2021 12 PARTS WERE DISCOVERED WITH DEFECTS (CAPTURED ON (B)(4)). ON (B)(6) 2022, AN ADDITIONAL 12 PARTS WERE DISCOVERED WITH DEFECTS (CAPTURED ON (B)(4)). LATER ON (B)(6) 2022, AN ADDITIONAL 29 PARTS WERE DISCOVERED WITH DEFECTS (CAPTURED ON (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13593752 ↗
• MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN RAYNHAM¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE ATTACHED SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592483 ↗
• 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 13043710 ↗
• 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 12414128 ↗
• 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 12414109 ↗
• 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 11388388 ↗
• 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 11388334 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO MCL RUPTURE. REVISED FEMORAL COMPONENT AND TIBIAL POLY TO A SROM HINGE. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10291883 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A UNSTABLE KNEE AND NEEDED A CONVERSION TO A HINGE KNEE. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10162638 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD REPORTS PATIENT'S FOLLOW UP NOTES FOR HER ENCOUNTER WITH PHYSICIAN ON (B)(6) 2018 AS REPORTS OF ONGOING PAIN (WHEN ATTEMPTING TO STAND) POST REVISION OF RIGHT TOTAL KNEE ARTHROPLASTY (DOR (B)(6) 2017). RADIOGRAPHIC IMAGES GIVE NO INDICATION OF IMPLANT DEFECTS. PATIENT HAD SEEN A PAIN SPECIALIST AND RECEIVED A RADIOFREQUENCY ABLATION WITHOUT BENEFITS. PHYSICIAN'S DECISION WAS FOR PATIENT TO CONTINUE THERAPY AND FURTHER FOLLOW UPS WITH X-RAYS.

  Patient problems: No Code Available; Pain

  MAUDE report 9511486 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON HAD TO REVISE AN SIGMA TC3 AND MBT REVISION TIBIA DUE TO PATIENT DISCOMFORT AND INSTABILITY. SURGEON REMOVED ALL EXISTING IMPLANTS AND PERFORMED REVISION WITHOUT ANY INCIDENT.

  Patient problems: Discomfort; No Code Available

  MAUDE report 8623585 ↗
• InjuryNov 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 8111988 ↗
• InjuryNov 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 8111413 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REVISED ALL KNEE COMPONENTS AND REMOVED. DOI: (B)(6) 20018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7670129 ↗
• InjuryDec 15, 2017Loss 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. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2004. DOR: (B)(6) 2017 RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7120726 ↗
• InjuryDec 15, 2017Loss 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. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2004. DOR: (B)(6) 2017 RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7120690 ↗