SIGMA 96-2332Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295242130), received between Oct 18, 2017 and May 23, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR A POLY SWAP. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE

  Patient problems: Insufficient Information

  MAUDE report 19381457 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY EXCHANGE FOR LAXITY IN BOTH FLEXION AND EXTENSION. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17077762 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO KNEE PAIN AND INSTABILITY. UPON TAKING AN X-RAY, IT WAS SHOWN THAT THE NEUTRAL ADAPTER BOLT HAD BROKEN OFF AND WAS FLOATING IN THE PATIENTS KNEE. THIS MEANT THE FEMORAL COMPONENT HAD COME DISENGAGED FROM THE CEMENTED SLEEVE AND STEM CONSTRUCT. UPON OPENING THE KNEE, THE BROKEN BOLT AND FEMUR WERE TAKEN OUT EASILY. THE 5 DEGREE FEMORAL ADAPTER WAS STILL TAPER ENGAGED IN THE 20MM CEMENTED SLEEVE. THERE WAS LOOSENING REPORTED AT THE BONE/CEMENT INTERFACE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16683120 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF RIGHT REVISION TOTAL KNEE REPLACEMENT. PFC TC3 RP REVISION PROSTHESIS INSITU. DR. UNDERSTOOD TO HAVE IMPLANTED THE PFC TC3 RP PROSTHESIS AS A REVISION PROSTHESIS. NO KNOWLEDGE OR INFORMATION REGARDING THE ORIGINAL PRIMARY IMPLANT. NO KNOWLEDGE OF ANY PREVIOUS SURGERY DATES OR HOSPITAL WHERE IMPLANTED. ATTEMPTS MADE TO OBTAIN THIS INFORMATION WITHOUT SUCCESS. REVISION FOR STIFFNESS AND PAIN. PROPOSAL TO CONVERT TO AN SROM HINGE PROSTHESIS BY REVISING FEMORAL COMPONENT. THIS WAS ATTEMPTED BUT THE FEMORAL PROSTHESIS WAS UNABLE TO BE EXPLANTED DUE TO THE SIGNIFICANT DEGREE OF ENHANCED FIXATION. THE BEARING WAS EVENTUALLY THE ONLY IMPLANT REVISED AND REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 14929680 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HER LEFT KNEE REVISED 2007 TC3 RP CONSTRUCT. NO OR RECORD , THE EXACT DATE AND LOCATION ARE UNKNOWN EITHER. THIS PATIENT CAME INTO THE ER WITH AN INFECTED KNEE. I DO NOT HAVE LABS OR REPORTS TO CONFIRM THE INFECTION, I AM REPORTING WHAT THE SURGEON TOLD ME. SURGEON DID A THOROUGH I&D, DURING THE PROCEDURE THE PATELLA AND THE TIBIAL COMPONENT WERE LOOSE AT BONE TO CEMENT INTERFACE AND WERE EXPLANTED. UNKNOWN BONE CEMENT WAS USED. THE TC3 RP INSERT WAS ALSO EXPLANTED. THE FEMORAL COMPONENT WAS STILL WELL FIXED AND WAS LEFT IN SITU. THE PATIENT TOLD THE SURGEON PA THAT HER KNEE HAS HURT FOR THE LAST 2-3 YEARS. THE PATIENT ALSO HAD A SINUS TRACK OF PUSS ON THE BACK OF HER CALF THAT ORIGINATED FROM THE TIBIA. THIS KNEE WAS OBVIOUSLY INFECTED FOR A LONG TIME AND THE PATIENTS BONE QUALITY WAS TERRIBLE. SURGEON CEMENTED A TC3 RP INSERT IN THE TIBIA WITH ANTIBIOTIC CEMENT, SURGEON DID NOT WANT TO CEMENT ANOTHER METAL BASE PLATE IN WHILE THERE IS AN ACTIVE INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2007, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 12370324 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE DOCTOR DECIDE TO REMOVE ALL COMPONENTS DO TO THIS INFECTION. IT WAS ALSO REPORTED THAT A FEMORAL IMPACTOR TIP BROKE OFF DURING THIS SURGERY. A COMPETITOR CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 11754516 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS POSSIBLE INFECTION. SURGEON REMOVED THE POLY AND WASHED OUT THE KNEE WITH IRRIGATION AND A BETADINE WASH TO HELP FIGHT OFF ANY INFECTION AND REPLACED WITH A THICKER POLY TO HELP WITH STABILIZATION. NO SURGICAL DELAY. DOI: (B)(6) 2014; DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11332047 ↗
• InjuryMar 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9832619 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN & STIFFNESS. SYNOVECTOMY AND POLY EXCHANGE PERFORMED. DOI: (B)(6) 2017; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9417899 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO KNEE PAIN. IT WAS ALSO REPORTED THAT THE PATELLA WAS "HOT" ON BONE SCAN. THE SURGEON REPLACED THE PATELLA WITH ROUND DOME 32 MM. THE OLD PATELLA IMPLANT WAS ANOTHER IMPLANT COMPANIES. DOI: (B)(6) 2017. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9369080 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SOME ISOLATED FEMORAL PAIN. DOI: 1-2 YEARS AGO, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8605447 ↗
• InjuryNov 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 7002134 ↗
• InjuryOct 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6959598 ↗