P.F.C. SIGMA 96-2112Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295241119), received between Dec 28, 2017 and Nov 6, 2025 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A WASHOUT AND LINER SWAP. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23489840 ↗
• InjuryNov 3, 2025Naturally Worn; Naturally Worn

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO LOOSE FEMORAL AND TIBIAL COMPONENTS. NON-ARTICULAR SURFACES SHOWS NO CEMENT REMAINING. CEMENT MANUFACTURER IS UNKNOWN. EXTENSIVE POLY DEBRIS NOTED AS WELL. TIBIAL INSERT SHOWS MODERATE YELLOWING.

  Patient problems: Insufficient Information

  MAUDE report 23456541 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND SWAPPED POLY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15968288 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LCL TORE AND BECAME UNSTABLE. NO FURTHER INFORMATION IS AVAILABLE. THERE IS NO REPORTED LOOSENING. THERE IS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2009; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 14601551 ↗
• InjuryJul 12, 2021Adverse 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) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12154565 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2008. DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9916347 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED KNEE. POLY EXCHANGE WAS DONE. NO OTHER INFORMATION AVAILABLE. DOI: (B)(6) 2011; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9131115 ↗
• InjuryJan 17, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT SIGMA PS/RP REVISION SYNOVECTOMY INSERT EXCHANGE WAS DONE SECONDARY TO RHEUMATOID ARTHRITIS. INSERT EXPLANT SHOWS SIGNIFICANT OXIDATION AND WEAR. EXPLANT TO BE RETURNED. POST WAS CUT BY SURGEON DURING REMOVAL.

  Patient problems: No Code Available; Rheumatoid Arthritis

  MAUDE report 8256656 ↗
• InjuryOct 4, 2018Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  THE CUSTOMER REPORTS THAT AN ABNORMAL WEAR OF THE POLYETHYLENE CAUSED A DISLOCATION OF THE LEFT TOTAL KNEE PROSTHESIS AFTER FALLING DOWN STAIRS.

  Patient problems: Not Applicable

  MAUDE report 7934149 ↗
• InjuryDec 28, 2017Fracture; Fracture

  DER STATES THE PATIENT FELL POST OP, PS RP INSERT SHEERED OFF AND THE RESULT WAS LATERAL LIGAMENT INSTABILITY. DEPUY CEMENT WAS ALSO USED. DOI: (B)(6) 2007; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 7150548 ↗