P.F.C. SIGMA 95-1032Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295230397), received between Jun 28, 2017 and Jan 19, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DECREASED RANGE OF MOTION : ADHESIONS EVENT IS NOT SERIOUS AND IS CONSIDERED MILD EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016. DATE OF EVENT (ONSET): (B)(6) 2016. (LEFT KNEE) TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA.

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

  MAUDE report 13290581 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10621489 ↗
• InjuryJun 28, 2019Naturally Worn; Unintended Movement; Naturally Worn; Unintended Movement

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011 FOR THE PATIENT HAS PARKINSON'S DISEASE. IT WAS REPORTED THAT DISLOCATION OCCURRED AFTER 2 WEEKS FROM THE PRIMARY SURGERY. AFTER THAT, DISLOCATION HAD OCCURRED 1-2 TIMES A MONTH AND FREQUENT DISLOCATION HAD RECURRED RECENTLY. THE FEMUR WAS DISLOCATED TO THE ANTERIOR WHEN THE PATIENT STOOD UP, IT WAS CONFIRMED THAT THERE WAS A SUSPECTED THE TIBIAL INSERT SPINOUT AT X-RAY. THUS, THE REVISION SURGERY WAS PERFORMED BY REPLACING THE TIBIAL INSERT (P/N: 951032) TO ONE SIZE BIGGER 17.5MM TIBIAL INSERT ON (B)(6) 2019. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. IT WAS CONFIRMED THAT WEAR OF THE TIBIAL INSERT ANTERIOR LIP AND THE TIBIAL INSERT POST. POSSIBLE CAUSE: INSUFFICIENT REMOVAL OF TISSUE SUCH AS OUTER MENISCUS, INSUFFICIENT GAP MANAGEMENT AT THE PRIMARY SURGERY (BECAUSE THE EXTENSION GAP WAS LOOSE THAN FLEXION GAP). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8743967 ↗
• InjuryApr 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  SUBJECT: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. REVISION OF INSERT. DOI: (B)(6) 2005. DOE: (B)(6) 2017. DOR: (B)(6) 2018, (LEFT KNEE).

  Patient problems: Joint Disorder

  MAUDE report 7442582 ↗
• InjuryJun 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATED THAT THE PATIENT EXPERIENCING INSTABILITY AND PAIN. PATIENT HAD A FALL AND DAMAGED TO PATELLAR TENDON WHICH HAD BEEN SURGICALLY REPAIRED. UPON EXAM IN OR, THE MCL WAS FOUND INCOMPETENT. ALL PARTS WERE REMOVED AND PATIENT CONVERTED TO A HINGE. NO INSTRUMENT WERE BROKEN.

  Patient problems: Pain

  MAUDE report 6674995 ↗