P.F.C. SIGMA 1581-40-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 10603295064909), received between Jun 28, 2017 and Aug 7, 2026 — classified as 108 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (40 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 110 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. Dartmouth 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 stiffness.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 50172954 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had a stiff knee. The doctor revised the construct except the patella to an Attune CRS W Short Stems on both the Fem and the tibia. DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown Knee.

  Patient problems: Muscular Rigidity

  MAUDE report 50100954 ↗
• InjuryJan 5, 2026Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AND FEMUR AT IMPLANT CEMENT INTERFACE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2011, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960366 ↗
• InjuryDec 31, 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 FOR Q4 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION FOR OSTEOLYSIS, POLYWEAR, AND PAIN

  Patient problems: Pain

  MAUDE report 23933329 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION FOR PAIN & INSTABILITY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23393573 ↗
• InjuryJul 31, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ASEPTIC TIBIAL LOOSENING OCCURRED BETWEEN THE TRAY AND CEMENT INTERFACE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22675908 ↗
• InjuryJan 31, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL LOOSENING AT CEMENT/TRAY(CEMENT TO IMPLANT) INTERFACE. THE CEMENT MANUFACTURER WAS DEPUY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21285111 ↗
• InjuryAug 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR, TIBIA AND PATELLA AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT HAD CHRONIC PAIN AND HAD A BONE SCAN THAT SHOWED LUCENCY WHICH AMONG EXAMINATION IMPLANTS WERE LOOSE INTRA-OP. THIS WAS A SIGMA PS FEMUR (SZ4) FB IMPLANT. FEMUR, TIBIA (4TIBIA), POLY, AND PATELLA WERE ALL EXPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20078031 ↗
• 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 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; Loss of Range of Motion; Unspecified Infection

  MAUDE report 19172300 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2023, PATIENT RECEIVED A PRIMARY RIGHT VELYS PLATFORM ROBOTIC ASSISTED TOTAL KNEE REPLACEMENT. UNSPECIFIED MANUFACTURER ANTIBIOTIC IMPREGNATED BONE CEMENT WAS UTILIZED. THE PATIENT HAD AT THE OUTSET OF THE PROCEDURE, A REMOVAL OF PREVIOUSLY IMPLANTED ORTHOPEDIC HARDWARE CONSISTING OF A PLATE, CEMENT, AND BONE SCREWS (MANUFACTURER(S) NOT IDENTIFIED)--NO OTHER DETAILS WERE PROVIDED EXCEPT THAT IT APPEARS TO HAVE BEEN REMOVED FROM THE PROXIMAL TIBIA, FOR WHICH THERE WAS SOME DEBRIDEMENT OF NECROTIC TISSUE. THE TOTAL KNEE ARTHROPLASTY WAS COMPLETED WITHOUT ISSUES.

  Patient problems: Unspecified Infection

  MAUDE report 18099537 ↗
• InjuryNov 7, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT IMPLANTS PUT KNEE AT 7 DEGREES MORE VALGUS THAN WHAT THE NATIVE KNEE WAS ORIGINALLY. FEMORAL AND TIBIAL COMPONENTS WERE LOOSE. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18083293 ↗
• InjuryOct 24, 2023Loss 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

  IT WAS REPORTED THAT HE IMPLANT WAS LOOSENING.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 17994608 ↗
• InjuryOct 5, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: Insufficient Information

  MAUDE report 17878656 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAINFUL KNEE AND UNDERWENT REVISION SURGERY FOR FULL REVISION. PRIMARY COMPONENTS REMOVED AND REPLACED WITH SIGMA REVISION TC3 FEMUR WITH SLEEVE AND STEM AND MBT REVISION RP TIBIAL WITH SLEEVE AND STEM. THERE WAS NO SURGICAL DELAY. DOI: UNK DATE 2012. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17730346 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PRIMARY KNEE AND EXPERIENCED POST CAR ACCIDENT KNEE PAIN.

  Patient problems: Pain

  MAUDE report 17606980 ↗
• InjuryJul 10, 2023Migration; Migration

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE ALLEGATION AGAINST THE FEMORAL AND INSERT? B. PLEASE PROVIDE THE PRODUCT DETAILS OF UNKNOWN BONE CEMENT C. HOW WAS THE CEMENT PREPARED FOR USE? D. WHAT EQUIPMENT WAS USED TO PREPARE/MIX THE CEMENT? E. WHAT WAS THE TIMING TO MIX AND THE TIME BETWEEN MIXING AND SETTING? F. WHAT EQUIPMENT WAS USED TO DELIVER THE CEMENT? G. WAS THE PRODUCT AVAILABLE FOR RETURN? ANSWERS: A. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. THE INSERT IS ATTACHED TO THE TRAY AND HAS TO BE REMOVED TO REMOVE THE TRAY. THE FEMUR, WHILE WELL FIXED, COULD NOT BE USED WITH REVISION COMPONENTS WHICH WAS THE SURGEON'S INTENTION, SO IT WAS REMOVED B ALL KNOWN DETAILS WERE NOTED IN PREVIOUS SUBMISSION. C. SURGEON ROUTINELY HAS CEMENTED MIXED BY HAND IN A BASIN WITH A TONGUE DEPRESSOR. D. SEE "C" E. UNKNOWN, UNTIL MIXED??? F. TONGUE DEPRESSOR DIRECTLY TO COMPONENTS, AND HAND PACKED INTO BONE AFTER PULSED LAVAGE AND DRYING G. NO.

  Patient problems: Insufficient Information

  MAUDE report 17287857 ↗
• InjuryJun 27, 2023Adverse 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 INFECTED KNEE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17208835 ↗
• InjuryApr 27, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: Pain

  MAUDE report 16824315 ↗
• InjuryMar 14, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT STATED THAT "I HAD BILATERAL KNEE REPLACEMENTS PERFORMED (B)(6) 2011 WITH SIGMA IMPLANTS. MY ORTHOPEDIC SURGEON IN (B)(6), MD SAID THE KNEES WOULD LAST 15-20 YEARS. HAVING SIGNIFICANT PAIN IN BOTH KNEES WHILE CYCLING PROMPTED A VISIT TO DR. ON (B)(6) 2021 WHERE HE INFORMED ME THAT THE HARDWARE HAS COME LOOSE INDICATING A REVISION IS NEEDED. THIS IS WELL SHORT OF THE 15-20 YEARS LIFESPAN OF THE SURGERY. I HAD A CYCLING GOAL TO DO RAAM (RACE ACROSS AMERICA) AND HAD TO CANCEL A QUALIFIER IN LATE (B)(6) IN UTAH. I WAS HOPING TO BECOME THE FIRST 70+ YEAR OLD RIDER TO BE AN OFFICIAL FINISHER. NOW DUE TO REVISION IN THE KNEES, I'LL HAVE TO WAIT AT LEAST 2 YEARS.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16536355 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16140233 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION TKR AS PART OF A SECOND STAGE DUE TO INFECTION. PATIENT HAS PRESENTED TO DR DAVID LIU AND UNDERGONE A POLY EXCHANGE AND WASHOUT. AT THIS STAGE, ON OPENING THE KNEE, THE KNEE WAS OBVIOUSLY PUSS AND INFECTED. THE KNEE WAS WASHED OUT AND THE POLY BEARING EXCHANGED. SAMPLES TAKEN AT THIS STAGE ARE POSITIVE FOR BACTERIA (SENSITIVE STRAIN). A DECISION WAS MADE TO GO BACK INTO THE KNEE AND REMOVE ALL COMPONENTS AS PART OF A TWO STAGE PROCEDURE. ON OPENING THE KNEE IT APPEARED RELATIVELY ANGRY BUT NOT OVERTLY PUSS. THE COMPONENTS WERE REMOVED, THE TISSUE DEBRIDED AND A TEMPORARY "KIWI" SPACER IMPLANTED (ATTUNE PS FEMUR AND AN ATTUNE PS RP INSERT) AS PART OF THE TEMPORARY SPACER. THESE WILL BE REMOVED IN DUE COURSE AND EXCHANGED FOR A REVISION SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 15974055 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASING PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2015; DATE OF EVENT: (B)(6) 2022; (LEFT KNEE). TREATMENT: AWAITING INTERVENTION; AWAITING RESULTS OF SYNOVASURE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15328740 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. DOI: (B)(6) 2013, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15163628 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR PE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE. TREATMENT: INJECTED MEDICATION (HEPARIN DRIP).

  Patient problems: Discomfort; Erythema; Pain; Pulmonary Embolism

  MAUDE report 15029242 ↗
• InjuryMay 20, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6), 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14461719 ↗

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-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-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-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-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-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-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
• 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