P.F.C. SIGMA 95-1030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295230373), received between Nov 5, 2019 and Sep 29, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Off-Label Use

  Patient problems: Unspecified Infection

  MAUDE report 50934319 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RPF INSERT WAS REVISED FOR INSTABILITY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024; DOR- (B)(6) 2024; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19477426 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF PATELLA AND POLY EXCHANGE. PATELLA SIZE 41 REVISED TO 32. RPF SIZE 3/10MM EXCHANGED TO SIZE 3/12.5MM. PATELLA AND RPF POLY WERE CUT TO REMOVE, LOT NUMBERS UNAVAILABLE. REASON FOR REVISION WAS BECAUSE PATIENT WAS UNHAPPY AND HAD INSTABILITY AFTER PRIMARY SURGERY, THEREFORE, POLY WAS UPSIZED AND PATELLA DOWNSIZED TO IMPROVE PATIENT OUTCOME. NO ADVERSE SYMPTOMS REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 11594798 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL KNEE REPLACEMENT: BONE LOSS AND LOOSENING FEMORAL AND TIBIAL COMPONENTS. NOT THOUGHT TO BE INFECTED AS PATHOLOGICAL BLOOD MARKERS NORMAL PRE-OP. UNCONFIRMED AND UNPROVEN SUGGESTION THE BONE LOSS AND LOOSENING MAY BE ASSOCIATED WITH A VASCULAR NECROSIS HOWEVER UNCONFIRMED AT THIS TIME.

  Patient problems: Injury; Necrosis; No Code Available

  MAUDE report 10606282 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BEARING EXCHANGE FOR TKR;PATIENT UNDERWENT PRIMARY TKR ON (B)(6) 2008, WHERE PFC RPF COMPONENTS WERE UTILIZED. PATIENT WAS DOING WELL UP UNTIL APPROXIMATELY 3 YEARS AGO WHEN SHE STARTED TO FEEL A LITTLE PAIN. THIS PAIN HAS PROGRESSED STEADILY. A DECISION WAS MADE TO OPEN THE KNEE AND REVIEW THE SOFT TISSUE BALANCE (UNBALANCED SOFT TISSUE WAS BELIEVED TO BE THE CAUSE OF HER PAIN). THE KNEE WAS TAKEN THROUGH A RANGE OF MOTION AND IT APPEARED TO BE LOOSE THROUGH THE ROM. A DECISION WAS MADE TO INCREASE THE THICKNESS OF THE POLY FROM A 10MM TO A 15MM.

  Patient problems: No Code Available; Pain

  MAUDE report 9520408 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION WAS DONE FOR CHRONIC PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 9278464 ↗