P.F.C. SIGMA 1581-25-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 10603295064565), received between Jul 31, 2017 and Aug 11, 2026 — classified as 126 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (47 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 133 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to Knee pain. Possible infection.Activity Level - Yes.DOI: Unknown.DOR: Unknown .Affected Side: Left Knee.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50216234 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity; Pain

  MAUDE report 50161947 ↗
• InjuryOct 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSE TIBIA AND FEMUR ON THE CEMENT IMPLANT INTERFACE. DOI: (B)(6) 2012. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23352761 ↗
• InjuryOct 15, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO TIBIAL COMPONENT WAS LOOSE AT THE CEMENT/IMPLANT TRAY INTERFACE. THE FEMORAL COMPONENT WAS NOT LOOSE. ALL COMPONENTS WERE REVISED. DOI: (B)(6) 2005, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23303281 ↗
• InjuryJun 2, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS A COMPETITOR. IT WAS REPORTED THAT THE DATE OF ORIGINAL IMPLANTATION WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22125838 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 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 ARTHROFIBROSIS AND PAIN.

  Patient problems: Adhesion(s); Pain

  MAUDE report 21986957 ↗
• InjuryOct 1, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. ALL IMPLANTS WERE REMOVED AND REVISED DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20345314 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISCOMFORT. THERE WAS NO LOOSENING. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 19382753 ↗
• InjuryApr 24, 2024Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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: Joint Laxity; Unspecified Infection

  MAUDE report 19172267 ↗
• InjuryNov 2, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: Pain

  MAUDE report 18055188 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A REVISION SURGERY WAS PERFORMED DUE TO THE SUSPECTED INFECTION. THE SAID IMPLANTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2014. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17650286 ↗
• InjuryAug 1, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING. THE LOOSENING INTERFACE WAS UNKNOWN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17433826 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF UNSTABLE KNEE AND WAS REVISED TO AN S-ROM HINGE KNEE DUE TO MEDICAL COLLATERAL LAXITY. NO EXPLANATION FOR LAXITY OF THE MCL LIGAMENT APPARENT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17142656 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 17107144 ↗
• InjuryJun 2, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL COMPONENT. DOI: (B)(6) 2008. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17046116 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT OF MINE HAD A LEFT KNEE REPLACEMENT ( OP NOTE ENCLOSED ). A 2.5 SIZED CRUCIATE SACRIFICING TKR WAS PERFORMED. HER POST OP RANGE ON THE TABLE WAS 3 - 120 DEGREES. ( ON THE RIGHT SIDE A SIZE 3 WAS INSERTED). A FEW MONTHS LATER THE RANGE OF MOVEMENT IN THE LEFT KNEE REDUCED AND IN OCTOBER 2021 WAS 30 - 75 DEGREES. THE KNEE WAS REVISED AT ANOTHER HOSPITAL. PATIENT HAS COMPLAINED TO ME: -THAT I HAVE USED TOO BIG A PROSTHESIS. -THE IMPLANT IS TOO DISTAL.

  Patient problems: Loss of Range of Motion

  MAUDE report 16992138 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND DEHISCENCE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: WOUND VAC.

  Patient problems: Wound Dehiscence

  MAUDE report 16784902 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE, EXPLANTED AND ANTIBIOTICS SPACER IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16572598 ↗
• InjuryMar 14, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY WITH THE SIGMA IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE IMPLANT LOOSENED. THERE IS ONLY INFORMATION THAT IT IS AN ASEPTIC LOOSENING. THE IMPLANTS WERE REMOVED ON (B)(6) 2023. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CEMENT ADHERES TO THE REMOVED STEM.

  Patient problems: Insufficient Information

  MAUDE report 16537189 ↗
• MalfunctionFeb 4, 2023Wrong Label; Wrong Label

  WE HAVE RECEIVED A CUSTOMER COMPLAINT THAT ANVISA'S REGISTER (B)(4) IS LABELED NOT TO MATCHING THE PRODUCT. THE LABEL MENTIONS "INSTRUMENTAL KIT. NON-STERILE-STERILIZE PRODUCT BEFORE USE." HOWEVER, THE PRODUCT IS ALREADY STERILE.

  Patient problems: Insufficient Information

  MAUDE report 16301924 ↗
• MalfunctionFeb 4, 2023Wrong Label; Wrong Label

  WE HAVE RECEIVED A CUSTOMER COMPLAINT THAT ANVISA'S REGISTER (B)(4) IS LABELED NOT TO MATCHING THE PRODUCT. THE LABEL MENTIONS "INSTRUMENTAL KIT, NON-STERILE-STERILIZE PRODUCT BEFORE USE", HOWEVER THE PRODUCT IS ALREADY STERILE.

  Patient problems: Insufficient Information

  MAUDE report 16301923 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SWELLING, HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022; (RIGHT KNEE). TREATMENT: ASPIRATION/DRAINAGE AND ORAL MEDICATION (CELEBREX).

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 15966449 ↗
• InjuryOct 21, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO TIBIA LOOSENING. THE LOOSENING WAS REPORTED AT CEMENT TO IMPLANT INTERFACE. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15649776 ↗
• InjuryOct 14, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT THE SURGERY FOR LEFT OA VIA TKA WITH THE PCF IMPLANTS IN QUESTION, THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, LOOSENING OF THE IMPLANTS WAS CONFIRMED ON (B)(6) 2022. A REVISION SURGERY IS PLANNED ON (B)(6) 2022. THE CAUSE OF THE LOOSENING IS CONSIDERED TO BE THAT THE TIBIAL IMPLANT HAS SUNK DUE TO THE FRAGILE BONE QUALITY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15605665 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. DIRECT EXCHANGE WAS DONE. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15365408 ↗

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-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-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-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-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-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-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-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-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-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-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