P.F.C. SIGMA 1581-20-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295063810), received between Sep 19, 2017 and Feb 3, 2026 — classified as 37 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (18 reports).

12 other recalls cover devices cleared under the same FDA submission (K032151, 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSTABILITY OF PREVIOUS IMPLANTS. REMOVED OLD IMPLANTS AND REVISED WITH NEW. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24245479 ↗
• InjuryAug 20, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT VOLUNTARY REPORT WAS RECEIVED (B)(4). ORIGINAL SURGERY DATE FOR RIGHT TOTAL KNEE ARTHROPLASTY (B)(6) 2021. PATIENT REQUIRED A KNEE REPLACEMENT (B)(6) 2025. WHEN THE OLD KNEE REPLACEMENT WAS REMOVED, THERE WAS SIGNIFICANT DAMAGE TO THE JOINT WHICH WAS NOT EXPECTED AND SEEMED TO BE A MANUFACTURING DEFECT. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 22849443 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT'S KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S PRIMARY SIGMA FIXED BEARING CRUCIATE RETAINING COMPONENTS (INSERT, TIBIAL TRAY, AND FEMUR) WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2022. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE

  Patient problems: Joint Laxity

  MAUDE report 20157573 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIGHT IN EXTENSION. DOI: UNKNOWN. DOR: ON (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 20018897 ↗
• InjuryApr 1, 2024Loss of or Failure to Bond; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Use of Device 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 86 REVISION CASES DUE TO FAILURE (NO MENTION OF WHY). 59/86 TIBIAL INSERTS WERE RETRIEVED. 2 OF THE 59 INSERTS EXHIBITED INEXPLICABLE ABNORMAL TYPE OF DAMAGE AND WERE EXCLUDED FROM THE FINAL ANALYSIS. FINAL COHORT INCLUDED 57 INSERTS. THERE WAS NO MENTION OF CEMENT MFG OR PATELLA IMPLANTS. RESULTS: 86 REVISIONS. ONLY 5 PATIENTS HAD A SINGLE DETECTED

  Patient problems: Insufficient Information; Joint Laxity; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19013000 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RIGHT KNEE PAIN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18283176 ↗
• InjurySep 5, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17681749 ↗
• InjuryJul 17, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO FELL AND LOOSENED HER TIBIA. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 17334180 ↗
• InjuryApr 28, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI- (B)(6) 2020. DOR- APRIL 13, 2023 AFFECTED SIDE- LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16833347 ↗
• InjuryFeb 22, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED. (B)(6) 2018: PRIMARY TOTAL KNEE ARTHROPLASTY WAS COMPLETED UTILIZING DEPUY SYNTHES IMPLANTS INCLUDING PATELLA RESURFACING. COMPETITOR CEMENT WAS USED. (B)(6) 2019: INJECTION TO LEFT KNEE FOR PAIN PERFORMED. (B)(6) 2020: PATELLA CLUNK IDENTIFIED AND THE PATIENT COMPLAINS OF PAIN AND INSTABILITY. (B)(6) 2020: PATIENT FALLS AND SUSTAINS A PERIPROSTHETIC FEMUR FRACTURE REQUIRING ORIF. THE PLATE AND SCREWS WERE MANUFACTURED BY SYNTHES. THE IMPLANTS DID NOT APPEAR TO BE REMOVED. (B)(6) 2021: X-RAY SHOWS PERSISTENT DISPLACEMENT OF A PARTIALLY HEALED DISTAL FEMUR FRACTURE WITH A LATERAL PLATE AND SCREW CONSTRUCT STABLE IN POSITION. (B)(6) 2021: INJECTION TO LEFT KNEE FOR PAIN PERFORMED. PAIN HAS PERSISTED DESPITE PHYSICAL THERAPY, BRACING, AND NERVE BLOCKS. (B)(6) 2021: SURGEON STATES THE LEFT KNEE IS LIGAMENTOUSLY LOOSE TO VARUS STRESS AND PAIN. (B)(6) 2021: X-RAY RESULTS STATE THERE IS A PERIPROSTHETIC FRACTURE IN THE DISTAL FEMORAL DIAPHYSIS THAT IS SUBACUTE TO CHRONIC. THERE IS ONE SHAFT WIDTH POSTERIOR DISPLACEMENT OF THE DISTAL FRACTURE FRAGMENT. THERE IS NO EVIDENCE OF HARDWARE FRACTURE OR LOOSENING. THE SURGEON STATES LEFT KNEE IS UNSTABLE LIKELY SECONDARY

  Patient problems: Fall; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16416933 ↗
• InjuryMay 20, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED AS TIBIAL LOOSENING OF A FB SIGMA. REMOVED TIBIA AND POLY. USED A TICKER POLY AND REPLACED WITH A STEMMED MBT REVISION TIBIA WITH SLEEVE. DOI: (B)(6) 2009. DOR:(B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 14461341 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO SUSPECTED LOOSENING. PATIENT COMPLAINED OF PAIN. X-RAYS REVEALED THE IMPLANTS COULD BE LOOSE. DURING THE SURGERY, THE DOCTOR HAD ISSUES WITH THE MBT REVISION REAMERS. THE HUDSON ADAPTER AND T-HANDLE FOR THE REAMERS WERE BOTH SLIPPING, MAKING THEM BOTH INOPERABLE. SURGICAL DELAY OF 5 MINUTES OCCURRED. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13619496 ↗
• InjuryMay 17, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. A DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2012. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11833054 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING IMPLANTS WERE REMOVED TODAY AT (B)(6) BY MR (B)(6) DURING KNEE REVISION SURGERY. FIXED FLEXION DEFORMITY OF 30DEG WAS THE REASON FOR REVISION. THIS WAS THE SECOND REVISION. THE FEMUR AND TIBIAL INSERT WERE IMPLANTED APPROX 2 YEARS AGO, THE TIBIA APPROX 4 YEARS AGO.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10484646 ↗
• InjuryAug 11, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE FOLLOWING IMPLANTS WERE REMOVED TODAY, (B)(6) 2020 AT (B)(6) BY (B)(6) FROM A RIGHT KNEE. SIZE 2 COCR TIBIA 158120000 LOT C8198678. SIZE 2 15MM STABILISED 158121015. LOT D14032412 INSERT . LOT NUMBER NOT A. ASEPTIC TIBIAL LOOSENING WAS THE REASON FOR REVISION. ORIGINAL SURGERY 2016.

  Patient problems: No Code Available

  MAUDE report 10392374 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INSTABILITY AND POLYETHYLENE INSERT WEAR. DATE OF IMPLANTATION: (B)(6) 2005, DATE OF REVISION: (B)(6) 2020, (LEFT KNEE). TREATMENT: REVISION OF TIBIAL TRAY AND TIBIAL INSERT.

  Patient problems: No Code Available

  MAUDE report 9898894 ↗
• InjuryMar 26, 2020Unintended Movement; Migration; Unintended Movement; Migration

  PATIENT WAS REVISED DUE TO TIBIAL SUBSIDENCE. DOI: (B)(6) 2016. DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9885925 ↗
• InjuryMar 23, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  INTERNALLY ROTATED TIBIAL COMPONENT. LEFT KNEE. REVISION DATE (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9865902 ↗
• InjuryJan 6, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT UNDERWENT A SECOND REVISION OF THE RIGHT KNEE ON (B)(6) 2017 SECONDARY TO SUSPECTED TIBIAL LOOSENING. INTRAOPERATIVELY, THE SURGEON CONFIRMED TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL AND PATELLAR COMPONENTS WERE WELL-FIXED. THE SURGEON DECIDED TO IMPLANT A DIFFERENT SYSTEM, THEREFORE HAD TO REVISE THE FEMORAL COMPONENT AS WELL DUE TO THIS. NO INTRAOPERATIVE COMPLICATIONS NOTED. DOI: (B)(6) 2016; DOR: (B)(6) 2016 (TIBIAL COMPONENTS); DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9553923 ↗
• InjuryNov 25, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED.

  Patient problems: No Code Available

  MAUDE report 9368933 ↗
• InjuryAug 26, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT MANUFACTURER WAS USED. PRIMARY PROCEDURE PERFORMED APPROXIMATELY 10 YEARS AGO. DOI: 10 YEARS AGO, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8932182 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR FAILED REVISION RIGHT TOTAL KNEE, DUE TO ASEPTIC LOOSENING. DOI: (B)(6) 2006; DOR #1: (B)(6) 2010; DOR #2: (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Foreign Body Reaction; Injury; Joint Disorder; No Code Available; Pain

  MAUDE report 8857184 ↗
• InjuryJul 11, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: UNK. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8780545 ↗
• InjuryJun 17, 2019Migration; Migration

  IT WAS REPORTED THAT THE TIBIA SUBSIDED. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8703453 ↗
• MalfunctionMay 7, 2019Use of Device Problem; Use of Device Problem

  SUBJECT ID: (B)(6). DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAYS - TIBIAL AP LUCENCIES : ABNORMAL RADIOGRAPHIC EVALUATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2018. DOE: (B)(6) 2019. (LEFT KNEE). FOLLOWUP MEDICAL RECORD STATED THE TIBIA WAS IN SLIGHT VARUS ALIGNMENT ON XRAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8588074 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032151, K241000. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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-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-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-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-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-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