SIGMA 1960-63-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295075295), received between Sep 6, 2017 and Jan 2, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING INCREASING ANTERIOR KNEE PAIN AND INSTABILITY. FEMORAL REVISION PERFORMED. NO SURGICAL DELAY, NO ADVERSE CONSEQUENCES FOR THE PATIENT. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21061352 ↗
• InjuryFeb 22, 2023Loss of or Failure to Bond; Patient Device Interaction Problem; Loss of or Failure to Bond; Patient Device Interaction Problem

  MEDICAL RECORDS RECEIVED. (B)(6) 2018: PRIMARY TOTAL KNEE ARTHROPLASTY WAS COMPLETED UTILIZING DEPUY SYNTHES IMPLANTS INCLUDING PATELLA RESURFACING. COMPETITOR CEMENT WAS USED. (B)(6) 2019: INJECTION TO LEFT KNEE FOR PAIN PERFORMED. (B)(6) 2020: PATELLA CLUNK IDENTIFIED AND THE PATIENT COMPLAINS OF PAIN AND INSTABILITY. (B)(6) 2020: PATIENT FALLS AND SUSTAINS A PERIPROSTHETIC FEMUR FRACTURE REQUIRING ORIF. THE PLATE AND SCREWS WERE MANUFACTURED BY SYNTHES. THE IMPLANTS DID NOT APPEAR TO BE REMOVED. (B)(6) 2021: X-RAY SHOWS PERSISTENT DISPLACEMENT OF A PARTIALLY HEALED DISTAL FEMUR FRACTURE WITH A LATERAL PLATE AND SCREW CONSTRUCT STABLE IN POSITION. (B)(6) 2021: INJECTION TO LEFT KNEE FOR PAIN PERFORMED. PAIN HAS PERSISTED DESPITE PHYSICAL THERAPY, BRACING, AND NERVE BLOCKS. (B)(6) 2021: SURGEON STATES THE LEFT KNEE IS LIGAMENTOUSLY LOOSE TO VARUS STRESS AND PAIN (B)(6) 2021: X-RAY RESULTS STATE THERE IS A PERIPROSTHETIC FRACTURE IN THE DISTAL FEMORAL DIAPHYSIS THAT IS SUBACUTE TO CHRONIC. THERE IS ONE SHAFT WIDTH POSTERIOR DISPLACEMENT OF THE DISTAL FRACTURE FRAGMENT. THERE IS NO EVIDENCE OF HARDWARE FRACTURE OR LOOSENING. THE SURGEON STATES LEFT KNEE IS UNSTABLE LIKELY SECONDARY

  Patient problems: Fall; Joint Laxity; Limb Fracture; Pain; Swelling/ Edema

  MAUDE report 16417069 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FRACTURE TO THE FEMUR FROM A FALL POST OP. THERE WAS NO SURGICAL DELAY, DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 15625145 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS TRAUMATIC FALL AND TORE HER MCL AND OPENED HER ARTHROPLASTY. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 12632678 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PATELLA BAJA. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11412589 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A FEMUR FRACTURE AND A FAILED SYNTHES PLATE. A CONVERSION TO A DISTAL FEMUR WAS DONE. DOI: UNKNOWN. DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10379824 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS UNSTABLE KNEE. IMPLANTS PUT IN BY SURGEON AT MOSES CONE IN 2006. DOI: 2006, DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9917456 ↗
• MalfunctionOct 1, 2019Contamination /Decontamination Problem; Difficult to Open or Close; Contamination /Decontamination Problem; Difficult to Open or Close

  IT WAS REPORTED THAT THE FEMORAL POSTERIOR STABILIZED LUGGED CEMENTED FEMUR WAS FOUND TO BE STUCK TO THE INNER PACKAGING WHEN IT WAS OPENED. WHEN REMOVED FROM THE PACKAGE, RESIDUE FROM THE INNER PACKAGING WAS FOUND TO BE LEFT ON THE FEMUR. THE SURGEON CHOSE TO OPEN A NEW IMPLANT OF THE SAME SIZE IN THE PATIENT'S BEST INTEREST. DOE: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9142236 ↗
• InjuryMay 16, 2019Use of Device Problem; Use of Device Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. FEMORAL COMPONENT WAS IN VARUS, CAUSING THE TIBIAL COMPONENT TO BECOME LOOSE. FEMUR, POLY AND TIBIAL TRAY WERE EXPLANTED AND ATTUNE REVISION COMPONENTS WERE RE-IMPLANTED. DOI: (B)(6) 2016; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8615818 ↗
• InjurySep 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. THE PATIENT HAS SUFFERED A FALL ON HER KNEE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH REVISION COMPONENTS.

  Patient problems: No Information

  MAUDE report 6846622 ↗