P.F.C. SIGMA 96-2052Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295240938), received between Aug 18, 2017 and May 13, 2022 — classified as 12 injuries.

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

• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANTERIOR PAIN POST FALL, HEMARTHROSIS EVENT IS NOT SERIOUS AND IS CONSIDERED MILD THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2004 DATE OF EVENT (ONSET): (B)(6) 2022 (LEFT KNEE) TREATMENT: ASPIRATED PREPATELLAR BURSA WITHOUT ANY PURULENT FLUID. PATIENT IS ALSO ON XARELTO SO A BLEED IS LIKELY.

  Patient problems: Cellulitis; Fall; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 14399736 ↗
• InjuryMar 19, 2022Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO PAIN, INSTABILITY AND POLY WEAR. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2003. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13827118 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A RIGHT KNEE FOR INSTABILITY. ORIGINAL SURGERY DONE IN 2006 BY DR. (B)(6) REG. MED. CTR. FULL KNEE REVISION TO ATTUNE REVISION. PATIENT IS A PLUMBER AND IS VERY ACTIVE. DOI: 2006, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12655702 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND EXPERIENCED INSTABILITY IN THE KNEE. THE DOCTOR REPLACED THE FEMUR, TIBIA AND INSERT WITH NEW COMPONENTS TO STABILIZE THE KNEE. DOI: (B)(6) 2013, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 12215393 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REMOVED A POLY INSERT FROM A PFC KNEE AND REPLACED IT WITH A THICKER ONE. A PATELLA WAS ALSO ADDED AS THE PATELLA WAS UNRESURFACED. THE REASON FOR REVISION WAS INSTABILITY. SIDE: LEFT. THE ORIGINAL SURGERY WAS CONDUCTED BY MR (B)(6) (FIRST NAME UNKNOWN) AT (B)(6)HOSPITAL ON (B)(6) 2001.

  Patient problems: Joint Laxity

  MAUDE report 11170433 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND ALL IMPLANTS WAS REMOVED AS FIRST PART OF TWO STAGE REVISION DUE TO INFECTION DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10057196 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE WERE PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9788042 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2014; DATE OF EVENT: (B)(6) 2019; DATE OF REVISION: (B)(6) 2019; (RIGHT KNEE). TREATMENT: REVISION OF INSERT.

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

  MAUDE report 9728363 ↗
• InjuryFeb 6, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8311809 ↗
• InjuryJun 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PATIENT HAD SLIGHT AMOUNT OF TIBIAL WEAR. SURGEON SUSPECTS TIBIA MIGHT BE LOOSE BUT IT WAS NOT. INSERT EXCHANGED AT REVISION. DOI: 2003; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7618780 ↗
• InjuryOct 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS DISCOMFORT AND UNDERWENT POLY EXCHANGE.

  Patient problems: Discomfort

  MAUDE report 6965813 ↗
• InjuryAug 18, 2017Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS PAIN WITH PROLONGED ACTIVITY. THE PATIENT ALSO HAD SECONDARY INSTABILITY AND POLY WEAR.

  Patient problems: No Code Available; Pain

  MAUDE report 6804887 ↗