P.F.C. SIGMA 1581-21-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295064015), received between Oct 19, 2018 and Mar 25, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.

• MalfunctionMar 25, 2024Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. B. CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY ¿DAMAGED¿? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. DAMAGED IN THE SENSE, OUTER BOX WAS IN COMPLETELY MOLTEN CONDITION. C. PLEASE CLARIFY IF THE SEAL WAS BREACHED IN ANY WAY? NO.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967469 ↗
• InjuryMar 6, 2024Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? - NO DELAY IN THE CASE. B. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? - INSERT WAS PROPERLY ALIGNED AND IMPACTED. C. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? - X RAYS LOOKED SUFFICIENT. D. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? - JOINT LINE WAS APPROPRIATE. THE INSERT WAS OLDER AND SEEMED TO LAST A WHILE. THERE MAY HAVE BEEN A FALL THAT WASN¿T REPORTED BY THE PATIENT OR FOR WHATEVER REASON THE POST WAS EXCESSIVELY HITTING THE BOX..

  Patient problems: Joint Laxity

  MAUDE report 18848182 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED ¿ I HAVE A KNEE REPLACED IN (B)(6) 2018. FOR 4 AND A HALF YEARS I SUFFERED FOR SWOLLEN KNEE AND PAIN. TWO MONTHS BACK I WENT TO MY DOCTOR AND HE GAVE ME COLLAGEN SHOTS. ANYWAY IT ISN'T SHOWED UP ON X-RAY. BUT THEN IT WAS PASSED JUNE I HAD ANOTHER KNEE REPLACED WITH DIFFERENT DOCTOR. HE SAID THAT THE FALL REPORT REMOVED IN THEM O I HAVE THE DEEP EFFECT IN DEPUY KNEE REPLACEMENT. I WAS THE PATIENT AND I HAVE COMPLAINT. IF SOMEONE WOULD CALL ME BACK AND SPEAK WITH ME I WILL BE HAPPY. THANK YOU. BYE.¿ DOI: (B)(6) 2018, DOR: (B)(6) 2022, LEFT KNEE.

  Patient problems: Fall; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16416944 ↗
• InjuryJun 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS SOME DISCOMFORT AND INFECTION . THE SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT AND REPLACED THE POLY. A SIZE 2 10MM STABILIZED POLY WAS REMOVED. THE SURGEON TRIALED THE 10MM INSERT AFTER PERFORMING A SYNOVECTOMY AND THOROUGHLY WASHING OUT THE KNEE. SURGEON DECIDED A LITTLE MORE TENSION WAS DESIRED AND TRIALED A 12.5MM INSERT. IT WAS FOUND TO BE SATISFACTORY AND THE REAL INSERT WAS OPENED AND IMPLANTED. CLOSING PROCESS BEGAN. SURGEON WAS UNSURE OF WHEN AND WHERE THE PATIENT HAD THEIR INITIAL KNEE SURGERY DONE. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Discomfort; No Code Available; Unspecified Infection

  MAUDE report 10114349 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 7986738 ↗