P.F.C. SIGMA 1581-12-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295063278), received between Sep 22, 2017 and Apr 5, 2022 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTED KNEE. THE SURGEON DID AN EXPLANT AND I&D WITH ANTIBIOTIC SPACER. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14014511 ↗
• InjuryMar 17, 2022Naturally Worn; Naturally Worn

  REVISION COMPLETED DUE TO INFECTION. I&D PERFORMED. POLY SHOWED SMALL AMOUNT OF OXIDIZATION AND WEAR. POLY WAS EXCHANGED FROM 2.5 8MM TO 2.5 10MM.

  Patient problems: Unspecified Infection

  MAUDE report 13801435 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED WHEN POLY WAS REMOVED AFTER DEBRIDEMENT OF AN INFECTED RETROGRADE FEMORAL NAIL. DOI : (B)(6) 2008. DOR : (B)(6) 2022. RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 13419648 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER WAS IMPLANTED. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT KNEE.

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

  MAUDE report 11142832 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. OP NOTES FROM THE PRIMARY SURGERY AND THE REVISION ARE NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION OUTSIDE OF THIS FORM IS ALSO NOT AVAILABLE. SURGERON DID THE PRIMARY KNEE ON (B)(6) 2019 AT LEHIGH VALLEY MUHLENBERG CAMPUS. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11121356 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS ACUTE INFECTION. ORIGINAL IMPLANT DATE WAS UNKNOWN. THE SURGEON REPLACED THE POLY AND DID A WASHOUT. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10574765 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TUESDAY, AUGUST 18TH IN DR. (B)(6) CLINIC WITH A PAINFUL AND EFFUSED RIGHT KNEE THAT THE PHYSICIAN SUSPECTED WAS INFECTED. THE PHYSICIAN ELECTED TO PERFORM A IRRIGATE AND DEBRIDEMENT PROCEDURE OF PATIENTS RIGHT KNEE AND ALSO REPLACE THE POLY IN ORDER TO GAIN EASIER ACCESS TO THE POSTERIOR KNEE. THE PHYSICIAN REMOVED THE POLY THAT WAS WELL FIXED AND SHOWED NO SIGNS OF WEAR. THE REMAINING INDEX COMPONENTS WERE WELL FIXED AND DID NOT NEED TO BE EXPLANTED. THE PHYSICIAN THEN IRRIGATED THE ENTIRE JOINT SPACE BEFORE IMPLANTING A KNEE POLY THE SAME SIZE AND THICKINESS OF THE ORIGINAL THAT WAS EXPLANTED. THE PHYSICIAN DID NOT BELIEVE ANY COMPONENTS DID NOT PERFORM AS EXPECTED. NO INSTRUMENTATION BROKE DURING THE SURGERY AND THERE WERE NOT TIME DELAYS.

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 10489661 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SAID PATIENT HAD SUFFERED A PUNCTURE WOUND TO THE HIP THAT THEY TOOK ANTIBIOTICS FOR. THE PATIENT STILL ENDED UP BECOMING ILL, AND LATER DEVELOPED SOME KNEE PAIN. THE KNEE WAS DONE ORIGINALLY AT BEAUMONT ROYAL OAK. THE SURGEON DECIDED IT WOULD BE BEST TO JUST WASH THE PATIENTS KNEE OUT AND CHANGE THE POLYETHYLENE. HE REMOVED A SZ 2.5 10 MM THICK CVD POLY AND OPTED TO IMPLANT A SZ 2.5 12.5 MM THICK CVD PLUS INSERT. HE RAN THE LEG THROUGH A RANGE OF MOTION AND FOUND IT TO BE SATISFACTORY. THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2015. DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9750224 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED ON 17 JUN 2019 WERE REVIEWED FOR MDR REPORTABILITY ON 3 SEP 2019. THE PATIENT UNDERWENT A SECOND RIGHT KNEE REVISION DUE TO DECREASED RANGE OF MOTION AND SCARRING. THE DEPUY TIBIAL INSERT WAS REVISED ALONG WITH COMPETITOR PRODUCTS. DOI: (B)(6) 2017. DOR: (B)(6) 2017, RIGHT KNEE.

  Patient problems: Loss of Range of Motion; No Code Available; Scarring

  MAUDE report 9109568 ↗
• InjuryFeb 14, 2019Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS PAIN. POLY WAS REMOVED & SAME SIZE UTILIZED AS A REPLACEMENT. PATELLA WAS RESURFACED. POLY HAD EVEN WEAR PATTERN PER SURGEON. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8340490 ↗
• InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND STIFFNESS. DOI:(B)(6) 2015, DOR:(B)(6) 2018, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7761376 ↗
• InjurySep 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS MEDIAL PAIN.

  Patient problems: Pain

  MAUDE report 6886604 ↗