SIGMA 94-0018Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295223443), received between Aug 28, 2017 and Nov 4, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 23468048 ↗
• InjuryOct 28, 2024Migration; Migration

  IT WAS REPORTED, THAT THE FEMORAL IMPLANT HAD SUBSIDED MEDIALLY. REVISED TO TC3 FEMUR. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20544120 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE OF LEFT DISTAL FEMUR. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022; (LEFT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Ambulation or Postural Difficulties; Limb Fracture; Pain

  MAUDE report 15392870 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SMALL AVULSION OF THE PATELLAR TENDON - EXTENSOR MECHANISM INSUFFICIENCY. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022, DATE OF EVENT: (B)(6) 2022, (LEFT KNEE). TREATMENT: INTRA-OP ORIF.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14515045 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASSOCIATED STUDY: ROTATING PLATFORM, ROTATING PLATFORM DATE OF EVALUATION: 9/FEB/2015. DATE OF ONSET: (B)(6) 2021 OPERATIVE SIDE: LEFT, DIAGNOSIS: ADHESIONS LT TKA, ADVERSE EVENT: ADHESIONS. ON (B)(6) 2021, THE PATIENT HAD A LEFT HYBRID TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS, END-STAGE, LEFT KNEE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WERE USED DURING THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A CLOSED MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS, STATUS POST LEFT TOTAL KNEE ARTHROPLASTY.

  Patient problems: Adhesion(s)

  MAUDE report 12467333 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. IN ADDITION TO THE PREVIOUS ISSUE OF IT BAND CROSSOVER PAIN, DURING THE EVALUATION AND INJECTION OF MEDICATION ON (B)(6) 2021, THE PATIENT WAS ALSO EXPERIENCING DISCOMFORT AND DIFFICULTY WALKING.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain

  MAUDE report 11629601 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR OPEN INCISION : WOUND DEHISCENCE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO BOTH DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: KEFLEX AND IODOFORM GAUZE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 10476570 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2018; DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9660969 ↗
• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO FLEXION INSTABILITY. DOI: (B)(6) 2014; DOR: (B)(6) 2018, (LEFT KNEE). FEMORAL COMPONENT AND INSERT REVISED.

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 8592625 ↗
• InjuryAug 8, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. REVISED TO TC3 AND PATELLA WAS WELL FIXED AND REMAINED IMPLANTED. DOI: (B)(6) 2010; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7761675 ↗
• InjuryAug 28, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AND TIBIA AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 6826247 ↗