P.F.C. SIGMA 1581-22-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295064190), received between Nov 15, 2018 and Aug 24, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH PAIN AND SWELLING SECONDARY TO A FALL ON (B)(6) 2022.

  Patient problems: Ambulation or Postural Difficulties; Fall; Pain; Swelling/ Edema

  MAUDE report 15289486 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE JOINT REPLACEMENT REQUIRED REVISION DUE TO INABILITY FOR THE PATIENT TO FLEX HIS KNEE, OF NOTE THE FEMUR HAD BEEN PREVIOUSLY REVISED AND WAS A STEMMED TC3 REVISION FEMUR, THE TIBIAL COMPONENT WAS STILL THE PRIMARY TIBIAL MBT COMPONENT ORIGINALLY IMPLANTED PREVIOUSLY. REASON FOR PREVIOUS PRIMARY AND REVISION IS UNKNOWN. UNABLE TO GAIN THE REFERENCE NUMBERS FROM OTHER IMPLANTS AS THE RELEVANT AREAS WERE COVERED BY CEMENT OR UNREADABLE.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 11648706 ↗
• InjuryNov 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A ROUTINE RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2019. PATIENT WAS PRESENTED TO SURGEON'S OFFICE WITH MECHANICAL NOISE, AND AN INABILITY TO FLEX HER KNEE AFTER A FALL. PATIENT WAS BROUGHT TO THE OPERATING ROOM AND IT IS NOTED ONCE ENTERING THE KNEE THAT THE LINER IS NO LONGER ENGAGED WITH THE TIBIA AND IS SITTING ABOVE IT. TIBIAL LINER IS BEING SENT TO DEPUY FOR ANALYSIS. SURGEON IS REQUESTING A RESPONSE LETTER. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9279103 ↗
• InjuryMar 25, 2019Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO LOT OF WEAR ON THE PATELLA AS WELL AS A LITTLE POLY WEAR AND INSTABILITY. SO THE SURGEON REMOVED PATELLA AND POLY AND PUT IN A THICKER POLY TO HELP WITH STABILITY AND RE-PREPPED THE PATELLA. DOI: UNKNOWN; DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8447492 ↗
• InjuryNov 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 8073995 ↗