P.F.C. SIGMA 96-0862Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295234289), received between Nov 4, 2017 and Mar 15, 2024 — classified as 15 injuries.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE BOLT INTERFACE. DOI: (B)(6) 2017 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE

  Patient problems: Insufficient Information

  MAUDE report 18912269 ↗
• InjuryMar 15, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE BOLT INTERFACE. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18912003 ↗
• InjurySep 20, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS IDENTIFIED THAT ON (B)(6) 2023, THERE WAS A REPORT FOR ASEPTIC LOOSENING LEFT REVISION (KNEE HAS BEEN REVISED IN THE PAST) DOI: (B)(6) 2013. DOR: UNKNOWN. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17781383 ↗
• InjuryMay 12, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT COMES FOR FURTHER DISCUSSION REGARDING PAINFUL BILATERAL TOTAL KNEE ARTHROPLASTIES. THE PATIENT HAD A RIGHT TOTAL KNEE IN 2006 AND REVISION IN 2019. SHE HAD A LEFT TOTAL KNEE IN 2006, A REVISION IN 2019 AND A SCOPE DEBRIDEMENT IN 2020. THE PATIENT CONTINUES TO HAVE ONGOING PAIN AND DISCOMFORT IN BOTH OF THE KNEES. THE PAIN IS DAILY. IT IS STARTING TO LIMIT HER ACTIVITIES. SHE HAS GOOD RANGE OF MOTION. SHE HAS SOME SWELLING AT TIMES. SHE HAS SOME GRINDING AND POPPING IN BOTH KNEES. THE LEFT KNEE HURTS MORE OFTEN THAN THE RIGHT KNEE. SHE DID PREVIOUSLY DISCUSS REVISION SURGERY WITH SURGEON. SHE WOULD LIKE TO PROCEED WITH STAGED TKA REVISIONS, LEFT ONE FIRST. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16918614 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT RESECTION WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14142019 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT RESECTION WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14141897 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR A DISLOCATED TC3 RP REVISION KNEE. PATIENT'S SOFT-TISSUE WAS DISCOVERED TO BE COMPROMISED UPON EXPOSURE OF THE JOINT. THE PATIENT WAS REVISED TO AN SROM HINGE WITHOUT ISSUE. THE INSERT WAS STILL IN THE TRAY AND DID NOT SPIN 90 DEGREES. THE FEMUR DISLOCATED DUE TO SOFT TISSUE INJURY.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 11505028 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR A DISLOCATED TC3 RP REVISION KNEE. PATIENT'S SOFT-TISSUE WAS DISCOVERED TO BE COMPROMISED UPON EXPOSURE OF THE JOINT. THE PATIENT WAS REVISED TO AN SROM HINGE WITHOUT ISSUE. THE INSERT WAS STILL IN THE TRAY AND DID NOT SPIN 90 DEGREES. THE FEMUR DISLOCATED DUE TO SOFT TISSUE INJURY.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 11505025 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS INFECTED. ALL REVISION COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PUT IN. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10149196 ↗
• InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. NOTE IN EXPLANTED PRODUCTS LEFT DISTAL AUGMENTS (2) SHARE THE SAME LOT NUMBER. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8784872 ↗
• InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. NOTE IN EXPLANTED PRODUCTS LEFT DISTAL AUGMENTS (2) SHARE THE SAME LOT NUMBER. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8784867 ↗
• InjuryApr 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE. SURGEON EXPLANTED FEMORAL COMPONENTS. REVISING WITH SIGMA TC3. CEMENT MANUFACTURER IS UNKNOWN. DOI:UNKNOWN DOR: (B)(6) 2018 LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7402611 ↗
• InjuryApr 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE. SURGEON EXPLANTED FEMORAL COMPONENTS. REVISING WITH SIGMA TC3. CEMENT MANUFACTURER IS UNKNOWN. DOI:UNKNOWN DOR: (B)(6) 2018 LEFT KNEE.

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 7402593 ↗
• InjuryNov 4, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS FATIGUE FAILURE OF THE TOTAL LEFT KNEE CONSTRUCT AND LOOSENING OF THE FEMORAL COMPONENT AT AN UNKNOWN INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. ON (B)(6) REVIEW OF THE PROVIDED X-RAYS FINDS THE FEMORAL ADAPTER BOLT HAS FRACTURED.

  Patient problems: No Information

  MAUDE report 7002227 ↗
• InjuryNov 4, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS FATIGUE FAILURE OF THE TOTAL LEFT KNEE CONSTRUCT AND LOOSENING OF THE FEMORAL COMPONENT AT AN UNKNOWN INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. (B)(6) 2017 REVIEW OF THE PROVIDED X-RAYS FINDS THE FEMORAL ADAPTER BOLT HAS FRACTURED.

  Patient problems: No Information

  MAUDE report 7002161 ↗