SIGMA 97-0472Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295250685), received between Nov 6, 2017 and Jul 21, 2025 — classified as 8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATENT HAD HIS KNEE REPLACED IN 2009 BY SURGEON AT HOSPITAL HE RECEIVED A PFC SIGMA CONSTRUCT. RECENTLY THE PATIENT CAME INTO THE ER AT HOSPITAL WHERE IT WAS DETERMINED HE HAD AN ACUTE UTI AS WELL AS AN INFECTED RIGHT AND LEFT KNEE. THE RIGHT KNEE WAS WASHED OUT BY THE DOCTOR AND THE SZ 5 X 12.5MM CVD PLUS POLY WAS EXPLANTED AND REPLACED WITH A SZ 5 X 15MM CVD PLUS INSERT. THE PATELLA, TIBIA, AND FEMUR WERE LEFT IN SITU. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22553817 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) , 2022 DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18184299 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND BROKE OPEN INCISION. I&D WITH POLY EXCHANGE WAS PERFORMED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 16494602 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. POLY WAS EXCHANGED. DOI- UNKNOWN. DOR- (B)(6) 2022. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15340984 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HYPER EXTENSION. DOI: UNKNOWN. DOR:(B)(6), 2021. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11859775 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD (AD (B)(6) 2019) REVIEWED. ON (B)(6) 2019 THE PATIENT HAD A REVISION OF THE TIBIAL POLYETHYLENE INSERT ONLY DUE TO PAIN AND LAXITY OF THE TOTAL KNEE. SURGICAL NOTES REPORT THAT PATIENT HAD EFFUSIONS, CHRONIC SYNOVITIS. THE OPERATIVE FINDINGS INCLUDED LIGAMENTOUS LAXITY OF THE RIGHT TOTAL KNEE.

  Patient problems: Edema; Joint Disorder; No Code Available; Pain; Synovitis

  MAUDE report 9328817 ↗
• InjuryDec 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON PERFORMED POLY EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 7113821 ↗
• InjuryNov 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7004459 ↗