P.F.C. SIGMA 98-6036Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295253105), received between Aug 10, 2018 and Jun 22, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF TIBIAL COMPONENT AND PATELLA IN A CEMENT TO IMPLANT INTERFACE. IT WAS REPORTED THAT IT WAS LOOSE TIBIAL TRAY VARUS. IT WAS REPORTED THAT THE TIBIAL TRAY ONLY HAD CEMENT ATTACHED TO LATERAL SIDE. ALL IMPLANTS WERE REVISED. A COMPETITOR CEMENT WAS USED. NO SURGICAL DELAY. DOI: 2001, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12041930 ↗
• InjuryJun 17, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE PATELLA AND TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT APPEARED UNSTABLE M/L. BONE SCAN SHOWED PATELLA WAS LOOSE AND CONVERTING THE FEMUR FROM PS TO CR. SURGEON NOTICE ALSO THE TIBIAL IMPLANT APPEARED LOOSE, EVEN THOUGH THE BONE SCAN DID NOT SHOW ANY SIGN OF LOOSENING. ALL FOUR IMPLANTS WERE REMOVED AND WAS REVISED TO A SIGMA TC3 IMPLANT. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8703302 ↗
• InjuryAug 10, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT REPORTED PERSISTENT KNEE CAP PAIN AFTER YEARS OF GOOD FUNCTION. SURGEON SUSPECTED LOOSE PATELLA. LOOSE PATELLA(SINGLE PEG STYLE) CONFIRMED INTRAOPERATIVELY. IT WAS NOT GROSSLY LOOSE, BUT HAD MICRO MOTION PER THE SURGEON. LOOSENING WAS AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOME OF PATELLA EXHIBITED A LINEAR BAND OF WEAR FROM TOP TO BOTTOM ALSO GOOD BONE STOCK TO RE CEMENT NEW 3 PEG PATELLA AND LINEAR EXCHANGED WHILE IN KNEE. DOI: (B)(6) 2005; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7771871 ↗