P.F.C. SIGMA 86-4183Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295216452), received between Nov 17, 2017 and Feb 22, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 reports).

7 other recalls cover devices cleared under the same FDA submission (K830927, K961685); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A SIGMA TKA IMPLANTED AROUND THE YEAR 2000. ALL IMPLANTS WERE REMOVED AND REPLACED WITH ATTUNE REVISION. THE PATIENT COMPLAINED OF PAIN AND SURGEON FELT IT WAS TIME TO REMOVE THE OLDER KNEE AND REPLACE WITH AN ATTUNE. DOI- UNKNOWN DOR- (B)(6) 2024 AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18764279 ↗
• InjuryMar 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION OF A PFC TKR DONE IN 2006. MALE, LEFT SIDE. ON THE JOINT REGISTRY FORM, THE REASON FOR REVISION WAS DUE TO DEEP INFECTION, TIBIAL LOOSENING, FEMUR LOOSENING. WHEN EXPOSURE WAS DONE THE SURGEON NOTED SIGNIFICANT POLY WEAR AS SEEN IN THE PICS. ALL COMPONENTS WERE REMOVED AND ATTUNE REVISION WAS IMPLANTED. THE PATIENT NOTES WERE UNAVAILABLE SO I WAS UNABLE TO GET THE LOT NUMBERS FROM THE IMPLANT STICKERS. THE ONLY LOT NUMBER I WAS ABLE TO READ ON THE IMPLANTS WAS FOR THE ONE STATED IN THE IMPACTED PRODUCTS. 86-4183 PFC KEELED TIBIAL TRAY SZ 5. THE TIBIA WAS VERY LOOSE. AS YOU CAN SEE IN THE PIC THERE IS CEMENT ON THE IMPLANT, SO BOTH INTERFACES FAILED. THE FEMUR FAILED AT THE BONE-CEMENT INTERFACE.

  Patient problems: Unspecified Infection

  MAUDE report 16501657 ↗
• InjuryJan 13, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND LOOSENING OF THE FEMUR AND TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 1997; DOR: (B)(6) 2019; LEFT KNEE

  Patient problems: No Code Available

  MAUDE report 9582171 ↗
• InjuryNov 21, 2019Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION KNEE SURGERY REQUIRED FOR PAINFUL TOTAL KNEE PROSTHESIS. SURGEON WAS GOING TO PERFORM A PATELLA RESURFACING AS PRIMARY PLAN, HOWEVER A LARGE FEMORAL CYST WAS DETECTED AS WELL AS A POTENTIALLY LOOSE TIBIAL TRAY, SO AN ENTIRE KNEE REVISION WAS PERFORMED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 9356058 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. THE FEMUR,TIBIA AND TIBIAL INSERT WERE REVISED. DOI: 2005; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9341355 ↗
• InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. I&D WAS DONE. DOI: (B)(6) 2003 DOR: UNKNOWN, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8703293 ↗
• InjuryDec 15, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  SURGEON: DR (B)(6). PROCEDURE: REVISION TKR. PATIENT UNDERWENT PRIMARY TOTAL KNEE REPLACEMENT APPROXIMATELY 10 YEARS AGO WHERE PFC CR CEMENTED COMPONENTS WERE UTILISED ((B)(6), ((B)(6) HOSPITAL). PATIENT HAS PRESENTED FOR FOLLOW UP AND A PAINFUL KNEE. X RAYS SHOW A LARGE GRANULOMA IN THE PROXIMAL TIBIA, JUST BELOW THE TIBIAL TRAY. A DECISION WAS MADE TO REVISE THE JOINT. JOINT WAS REVISED ON (B)(6) 2017 (DR (B)(6)). ON OPENING THE JOINT THE TIBIAL TRAY WAS FOUND TO BE LOOSE. THE PROXIMAL TIBIA HAD AN EXTENSIVE GRANULOMA. THE FEMORAL COMPONENT WAS RELATIVELY WELL FIXED. FEMORAL AND TIBIAL COMPONENTS WERE REMOVED AND THE PATELLA COMPONENT LEFT IN SITU. A STEMMED TIBIAL AND FEMORAL PFC TC3 WAS IMPLANTED. KNEE APPEARED STABLE. MALE PATIENT INITIALS (B)(6), AGED (B)(6), DOB (B)(6). X-RAYS AVAILABLE. UNKNOWN JRN: PFC SIGMA CR CEMENTED FEMUR SIZE 5 RIGHT = DISCARDED. UNKNOWN JRN: PFC SIGMA CUCIFORM KEEL TRAY SIZE 5 = DISCARDED. UNKNOWN JRN: PFC SIGMA CR BEARING SIZE 5 X? = DISCARDED. UNKNOWN JRN: PFC PATELLA = STILL IMPLANTED.

  Patient problems: Granuloma; Pain

  MAUDE report 7122096 ↗
• InjuryNov 17, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN, LIMITED ROM 20-80 DEGREES, OSTEOLYSIS AND TIBIAL TRAY LOOSENING AT UNKNOWN INTERFACE.

  Patient problems: Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 7042383 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K830927, K961685. One submission often covers many models, so check the product and lot details in each record.

• Z-0057-2007 · Sep 14, 2006 · Terminated
  Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
• Z-1315-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 97-0340.
• Z-1320-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 15.0 mm; Ref 97-0373.
• Z-1319-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 10.0 Ref 97-0371.
• Z-1318-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361.
• Z-1317-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353.
• Z-1316-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352.