P.F.C. SIGMA 1581-30-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10603295064893), received between Jun 29, 2017 and Aug 7, 2026 — classified as 149 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (71 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 152 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. (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 instability. The non-articular surface of the fixed-bearing polyethylene tibial insert shows moderate yellowing .

  Patient problems: Joint Laxity

  MAUDE report 50174154 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient had an infected total knee. There is no implant record available so no lot codes are provided. All implants were removed. There was no loosening. No more information known.Affected Side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50139958 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SIGMA IMPLANTS WERE IMPLANTED IN (B)(6) OF 2011. PATIENT WAS HAVING KNEE PAIN. CONSTRUCT WAS REPLACED WITH ATTUNE REVISION IMPLANTS. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 25414451 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, AND EXCHANGED FOR A COMPONENT AND TIBIA. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23622512 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH 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 PAIN AND HYPEREXTENSION DEFORMITY. TIBIAL INSERT SHOWED MODERATE YELLOWING.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 23468046 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22645157 ↗
• 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. AT REMOVAL THERE WAS MINOR YELLOWING ON THE TIBIAL INSERT.

  Patient problems: Adhesion(s); Pain

  MAUDE report 21986750 ↗
• MalfunctionFeb 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED WHEN THE SCRUB TEAM WAS PREPPING FOR A TIBIA REPAIR, THE IMPLANT PACKAGING HAD A FOREIGN OBJECT OF A RED SPEC INSIDE. ALTHOUGH THIS RED SPEC WAS ON THE OUTER PART OF THE POLYSTYRENE AND NOT TOUCHING THE ACTUAL IMPLANT, THE CONSULTANT DID NOT WANT TO USE IT IN CASE OF RISK OF INFECTION.

  Patient problems: Insufficient Information

  MAUDE report 21291741 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIBIA PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21068835 ↗
• InjuryDec 10, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF FEMORAL AND TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2011. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20896455 ↗
• InjuryOct 9, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? N/A. B. PLEASE CONFIRM WAS THERE ANY LOOSENING, IF YES, ON WHAT INTERFACE DID THE LOOSENING OCCURRED? TIBIAL SURFACE.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 20409846 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19447890 ↗
• InjuryApr 24, 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: Joint Laxity; Unspecified Infection

  MAUDE report 19172290 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR AN INFECTION. ALL IMPLANTS WERE REMOVED. A SPACER WAS PLACED. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18867259 ↗
• InjuryDec 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO TIBIA LOOSE. DOI: (B)(3) 2011. DOR: (B)(3) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18290940 ↗
• InjuryOct 19, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AT UNKNOWN INTERFACE. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17966057 ↗
• InjurySep 28, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO COMPONENT LOOSENING BETWEEN BIOMET COBALT CEMENT AND TIBIAL TRAY. THERE WAS NO SURGICAL DELAY. ACTIVITY LEVEL WAS YES. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17835050 ↗
• InjuryJun 22, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT KNEE REVISION BECAUSE OF LOOSENING OF THE TIBIAL COMPONENT AT THE IMPLANT AND CEMENT INTERFACE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2011. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17182768 ↗
• InjuryJun 21, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO A LOOSE TIBIAL IMPLANT. ALL PRIMARY HARDWARE WAS REVISED AND REPLACED WITH ATTUNE REVISION COMPONENTS. NO SURGICAL DELAY WAS THERE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17169757 ↗
• InjuryJun 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION OF FEMORAL/TIBIAL COMPONENT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2017, DATE OF REVISION: UNK, DATE OF EVENT: (B)(6) 2023, (RIGHT KNEE). TREATMENT: REVISION; REVISED COMPONENTS UNSPECIFIED.

  Patient problems: Joint Dislocation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17116304 ↗
• InjuryJun 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED VIA TKA WITH PFCS. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023 DUE TO LOOSENING. THE EVENT DATE AND THE REASON FOR THE LOOSENING IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17098425 ↗
• InjuryApr 26, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. TWO DEPUY CEMENTS WERE USED. DOI: (B)(6) 2009; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16815779 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO POLYETHYLENE WEAR, NO MALPOSITION, COMPONENTS WERE NOT UNDERSIZED ON THE PRIMARY SURGERY, NO LOOSENING AND NO SURGICAL DELAY REPORTED.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 16452434 ↗
• 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 16301921 ↗
• 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 16301920 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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