P.F.C. SIGMA 1581-15-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295063582), received between Jun 26, 2018 and Apr 24, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

51 other recalls cover devices cleared under the same FDA submission (K033272, K241000); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ARTICLE ENTITLED ¿3D POLYETHYLENE WEAR ANALYSIS AFTER PRIMARY CRUCIATE-RETAINING TKA FAILURE USING OPTICAL SCANNING AND CAD MODELS REFERENCES¿ WRITTEN BY MATEJ VALIC, VESNA LEVA¿IC, INGRID MILO¿EV, MATEJA BLAS, EVA PODOV¿OVNIK, JAKA KOREN, AND RIHARD TREB¿E WAS REVIEWED. OUR PURPOSE WAS TO IDENTIFY (A) WHETHER VOLUMETRIC WEAR (ADJUSTED FOR TIME IN-SITU) SIGNIFICANTLY DIFFER AMONG GROUPS OF COMMON CAUSES OF TKA FAILURE, (B) WHETHER THERE IS A CHARACTERISTIC WEAR DISTRIBUTION PATTERN FOR A COMMON CAUSE OF TKA FAILURE, AND (C) WHETHER NOMINAL INSERT SIZE (SMALL VS LARGE) AND COMPONENTS SIZE RATIO (FEMUR-TO-INSERT) INFLUENCE ON VOLUMETRIC WEAR RATES. THE STUDY INCLUDED PATIENTS THAT HAD BEEN IMPLANTED WITH A SIGMA TKA (CEMENTED TIBIAL TRAY AND POROUS COATED FEMORAL COMPONENT). WITHIN THE PATIENT THAT MET THE CRITERIA, THERE WERE NOTED TO BE (B)(4) REVISION CASES DUE TO FAILURE (NO MENTION OF WHY). (B)(4) TIBIAL INSERTS WERE RETRIEVED. (B)(4) INSERTS EXHIBITED INEXPLICABLE ABNORMAL TYPE OF DAMAGE AND WERE EXCLUDED FROM THE FINAL ANALYSIS. FINAL COHORT INCLUDED (B)(4) INSERTS. THERE WAS NO MENTION OF CEMENT MFG OR PATELLA IMPLANTS. RESULTS: (B)(4)REVISIONS. ONLY (B)(4) PATIENTS HAD A SIN

  Patient problems: Unspecified Infection

  MAUDE report 19172262 ↗
• InjuryMar 8, 2023Naturally Worn; Naturally Worn

  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. DOI: 2006, DOR: (B)(6) 2023, LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16502361 ↗
• InjuryMar 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL ON HIS KNEE AND OPENED UP INCISION INCLUDING RETINACULUM. I&D AND POLY EXCHANGE WERE PERFORMED AND CLOSED. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 13851983 ↗
• InjuryOct 26, 2020Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED FOR RECURRENT HEMARTHROSIS. THERE WAS POSTERIOR MEDIAL WEAR OF THE TIBIAL INSERT. SOFT TISSUE RELEASES WERE PERFORMED AND A 2MM THINNER INSERT, CVD PLUS WAS USED TO OBTAIN PROPER SOFT TISSUE BALANCE. NO OTHER COMPONENTS WERE REVISED. DOI: 2010. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 10734055 ↗
• MalfunctionJun 29, 2020Fracture; Fracture

  HIGH VOLUME SURGEON WENT TO IMPACT THE DEFINITIVE LINER AND THE ANTERIOR LOCKING MECHANISM BROKE. FORTUNATELY, THERE WAS A LOAN ONE AVAILABLE. THIS HAPPENED AT THE END OF THE CASE.

  Patient problems: No Code Available

  MAUDE report 10208400 ↗
• MalfunctionDec 13, 2018Break; Break

  PIECE OF PE BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8159790 ↗
• InjuryJun 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF PFC TKJR; (B)(6) HOSPITAL, "(B)(6)" 2018. PRIMARY IMPLANT YEAR 2005. REVISION OF (R) TKJR DUE TO OSTEOLYSIS SURROUNDING THE JOINT. ¿EVERYWHERE¿ (AS PER SURGEON). JNJ REPRESENTATIVES - (B)(6) WERE PRESENT FOR THE CASE. ALL PFC IMPLANTS REMOVED AND ATTUNE REVISION PERFORMED. MALE PATIENT ID: (B)(6). IMPACTED PRODUCT: UNKNOWN JRN: PFC CRUCIFORM KEEL TRAY SIZE 5 FB / LOT # UNKNOWN, UNKNOWN JRN: PFC CR FEMUR ? SIZE / LOT # UNKNOWN, UNKNOWN JRN: PFC CR FB INSERT SIZE 5 / LOT # UNKNOWN.

  Patient problems: Osteolysis

  MAUDE report 7637378 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033272, K241000. One submission often covers many models, so check the product and lot details in each record.

• Z-0412-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or de
• Z-0415-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or
• Z-0416-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or d
• Z-0417-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or de
• Z-0422-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definit
• Z-0420-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive
• Z-0421-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or defin
• Z-0418-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definiti
• Z-0419-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive
• Z-0413-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or def
• Z-0414-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or defin
• Z-0423-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definit
• Z-1156-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581-12-010.
• Z-1187-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-24-015.
• Z-1157-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 17.5 mm; Ref 1581-12-017.

…and 36 more.