SIGMA 86-6468Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295217176), received between Nov 6, 2017 and Jul 7, 2025 — classified as 24 injuries.

The most frequently reported specific device problem is “Fracture” (11 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2025Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. UPON EXPLANT, IT WAS REALIZED THE STEM AND SLEEVE JUNCTION WAS BROKEN. SURGEON REPORTED A FALL PRIOR TO REPORTS OF INSTABILITY. THERE WAS LOOSENING OF SLEEVE AND SROM FEMUR AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 22423919 ↗
• InjuryJun 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT PATIENT'S DISTAL FEMORAL REPLACEMENT WAS REVISED BECAUSE THE 13X90 CEMENTED STEM BROKE OFF AT THE FEMORAL SLEEVE JUNCTION. THERE WAS LOOSENING OF FEMORAL SLEEVE AT NON-CEMENTED INTERFACE DUE TO STEM BREAKING. UNKNOWN CEMENT WAS USED. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22213985 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED ON A CALL ON (B)(6) 2025, THE PATIENT HAD A ROD PLACED AND A REVISION OF THE KNEE WAS PERFORMED DUE TO LOWER FEMUR FRACTURE (SHATTERED) ON (B)(6) 2025. SINCE THAT TIME, THE PATIENT HAS HAD MULTIPLE "PARTIAL DISLOCATIONS" WHERE THE KNEE FEELS LIKE IT POPS OUT AND THEN HAS TO BE PUSHED BACK INTO PLACE. THE PATIENT HAS BEEN EXPERIENCING SEVERE PAIN DURING THOSE EPISODES.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21445516 ↗
• InjuryApr 10, 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 PAINFUL TKA. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Pain

  MAUDE report 19082435 ↗
• InjuryNov 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE CEMENTED FEMORAL STEM BROKE FROM THE CEMENTED FEMORAL SLEEVE. IT WAS UNKNOWN IF THERE WAS AS SURGICAL DELAY. DOI- (B)(6) 2022. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18094205 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR CHRONIC EFFUSION, DECREASED ROM, AND INCREASED PAIN. FEMORAL REVISION AND POLY EXCHANGE PERFORMED. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17928207 ↗
• 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 17878660 ↗
• InjuryAug 25, 2023Fracture; Fracture

  PATIENT STATED THEY WERE GOING DOWN SOME STAIRS AND FELT A POP IN HIS KNEE. LOOKING AT THE X-RAYS IT APPEARED THE STEM BROKE AT THE JUNCTION BETWEEN THE STEM AND FEMORAL SLEEVE. THEY REMOVED AND REVISED. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17622756 ↗
• 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 17334197 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED TO (B)(6): "SUDDEN INCREASE OF PAIN IN THE LEFT KNEE JOINT AFTER A FALL EVENT."

  Patient problems: Fall; Pain

  MAUDE report 13928010 ↗
• InjuryJul 22, 2021Loss of or Failure to Bond; Device Dislodged or Dislocated; Loss of or Failure to Bond; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING AT THE STEM-SLEEVE JUNCTION. THE STEM WAS SPINNING LOOSE FROM THE SLEEVE IN THE CANAL. DOI: UNKNOWN. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12210952 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS TO CAPTURE PATIENTS¿ PRIOR REVISIONS REPORTED IN (B)(4). THIS WAS THE TENTH REVISION FOR THIS PATIENT; PATIENT UNDERWENT A LEFT PRIMARY TOTAL KNEE REPLACEMENT (TKR) ON (B)(6) 2009. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020 DUE TO TIBIAL PAIN.

  Patient problems: Pain

  MAUDE report 12168018 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2004, THE PATIENT UNDERWENT A BILATERAL KNEE ARTHROPLASTY DUE TO ARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED IN BOTH KNEES. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2011, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS INFECTION, COMPARTMENT SYNDROME, DISLOCATION, INSTABILITY, AND ABSCESS. ALL COMPONENTS WERE NOTED TO BE REMOVED AND REPLACED WITH ARTICULATING ANTIBIOTIC SPACER. UNKNOWN MANUFACTURER PRODUCTS WERE IMPLANTED DURING THE REVISION.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation; Joint Laxity

  MAUDE report 11334459 ↗
• InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE SURGICAL IRRIGATION AND DEBRIDEMENT WITH WOUND CLOSURE DUE TO WOUND DEHISCENCE AND CONTINUED INFECTION. UPON ENTERING THE WOUND, NECROTIC TISSUE WAS EXCISED, AND A THOROUGH IRRIGATION WAS DONE. NO IMPLANTS WERE REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Necrosis; Wound Dehiscence

  MAUDE report 11223454 ↗
• InjuryOct 19, 2020Fracture; Fracture

  REVISION OF CEMENTED FEMORAL STEM 13X90MM RIGHT SIDE BECAUSE OF FRACTURE. DOI: (B)(6) 2018, DOR: (B)(6) 2020. A SURGICAL DELAY WAS NOT REPORTED.

  Patient problems: No Code Available

  MAUDE report 10697068 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE SWELLING/HEMARTHROSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF REVISION (INSERT): (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE). TREATMENT: SURGICAL IRRIGATION & DEBRIDEMENT, WITH NO REVISION OF PRODUCTS.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 10691171 ↗
• InjuryAug 20, 2020Fracture; Fracture

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE UNKNOWN COMPONENT AT THE CEMENT TO IMPLANT AND BONE TO CEMENT INTERFACE. THE SLEEVE/STEM INTERFACE BROKE. UNKNOWN CEMENT WAS USED. NO SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10431998 ↗
• InjuryFeb 17, 2020Fracture; Fracture

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE UNKNOWN COMPONENT AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. THE FEMORAL PRODUCTS WERE EXPLANTED. SZ 2.5 X 15MM PFC STAB POLY, TWO 8 MM POSTERIOR AUGMENT, TWO 8 MM DISTAL AUGMENT, SIZE 2 FEMUR, 13X90 CEMENTED STEM. NO LOT NUMBERS COULD BE READ. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9717133 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS UNSTABLE LCS. REVISED ONLY THE FEMUR AND LINER, WHILE KEEPING THE TIBIA COMPONENTS. ALSO REMOVED THE PATELLA COMPONENT. DOI: (B)(6) 2014; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9369490 ↗
• InjuryMar 26, 2019Fracture; Fracture

  THE PATIENT WAS REVISED DUE TO FRACTURE OF THE THREADS ON THE CEMENTED STEM AT THE SLEEVE/STEM JUNCTION. THE LPS FEMORAL CONSTRUCT WAS REVISED WITH ANOTHER LPS DISTAL FEMORAL REPLACEMENT WITH A 40MM SEGMENT AND A 12X125 CEMENTED STEM. THE POLY WAS ALSO REPLACED. DOI: (B)(6) 2018; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8452694 ↗
• InjuryMar 12, 2019Fracture; Fracture

  PATIENT REPORTED WITH PAINFUL AND UNSTABLE REVISION KNEE CONSTRUCT (TC3 FB WITH CEMENTED STEM). RADIOGRAPH SHOWED APPARENT BROKEN TIBIAL STEM EXTENSION AT THE STEM/TRAY INTERFACE. REVISED FB TRAY AND 13X90 CEMENTED STEM TO A 25MM RP BUILD-UP TIBIAL TRAY AND 13X90 CEMENTED STEM WITH A 10MM TC3 RP POLY RESULTING IN A STABLE CONSTRUCT. PATIENT EXPERIENCED POST-OP DEVICE MALFUNCTION. TIBIAL STEM EXTENSION SHEARED OFF AT THE STEM EXTENSION TIBIAL TRAY INTERFACE,

  Patient problems: No Code Available; Pain

  MAUDE report 8413265 ↗
• InjuryDec 21, 2018Loss of Osseointegration; Loss of Osseointegration

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE DISTAL FEMUR AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO STATED THAT IT APPEARS THAT THE SLEEVE DID NOT INGROWTH FOR LONG TERM STABILITY, THE CONSTRUCT BROKE AT THE STEM/SLEEVE JUNCTION.

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 8190102 ↗
• InjuryMay 22, 2018Fracture; Fracture

  DER STATES THAT THE 13X90MM STEM BROKE AT STEM/SLEEVE JUNCTION. THE STEM, FEMORAL SLEEVE, ADAPTOR, AND LPS SEGMENT WERE REMOVED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7533253 ↗
• InjuryNov 6, 2017Fracture; Fracture

  THE PATIENT WAS REVISED TO ADDRESS FRACTURED FEMORAL STEM AND LOOSENING OF THE FEMUR AT THE BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED.

  Patient problems: No Information

  MAUDE report 7003581 ↗