SIGMA 1960-74-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295075486), received between Oct 18, 2017 and Mar 21, 2024 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE PATELLA AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. PATIENT HAD A FALL SEVERAL YEARS AGO, POSSIBLY DISLODGED HIS PATELLA IMPLANT, DID NOT WANT SURGERY. CURRENTLY PATIENT HAS A KNOWN INFECTION. ALL PARTS WERE REMOVED AND A SPACER PUT IN W ANTIBIOTIC CEMENT. NO DELAY. NO LOT NUMBERS ARE READABLE ON THE COMPONENTS. DOI: (B)(6), 2018. DOR: (B)(6), 2024. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 18956239 ↗
• 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 15163627 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE JOINT INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. DOI: (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13508034 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUESTIONS: 1. WAS THE CEMENT PRODUCT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS AND QUANTITY OF THE CEMENT. 2. PLEASE CLARIFY, WAS THE PATELLAR IMPLANT REMOVED? 3. IT WAS INDICATED IN THE EVENT DESCRIPTION THAT PATIENT WAS REVISED WITH A THICKER POLY ON 3/10/20. WAS THIS BEING REPORTED? IF YES, PLEASE PROVIDE THE COMPLAINT NUMBER. 3.1. IF NONE REPORTED, PLEASE PROVIDE DETAILS OF THE PREVIOUS REVISION. 4. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? 5. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? 6. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? 7. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY. ANSWERS: 1. UNKNOWN WHAT CEMENT. 2. PATELLA WAS RETAINED. 3. ORIGINAL CASE # WAS 168118 ( I AM ATTACHING THE MDR AS THERE IS NO COMPLAINT # ON IT. 5-7. NO OTHER THAN THAT, I HAVE NO FURTHER INFORMATION.

  Patient problems: Joint Laxity

  MAUDE report 12638397 ↗
• InjuryJun 9, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD A LOOSE FEMUR AND EXPERIENCED INSTABILITY. DR. REPLACED IT WITH A TC3 FEMORAL REVISION WITH A PRESS FIT STEM AND SLEEVE SURGERY DELAY OF 75 MINUTES. PROCEDURE SUCCESSFULLY COMPLETED. PATIENT'S POLY AND PATELLA WERE WORN AND OXIDIZED. IT WAS REPLACED WITH AN AOX POLY ENCE.

  Patient problems: Joint Laxity

  MAUDE report 11968681 ↗
• InjuryOct 26, 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. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 6980129 ↗
• InjuryOct 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND SUSPECTED FEMORAL LOOSENING. IT WAS ALSO STATED THAT FEMUR WAS STILL FIXED TO BONE. UPDATE SEP 18, 2017: DER REVIEWED FOR REPORTABILITY. NOTED THAT ALTHOUGH REVISED TO ADDRESS POSSIBLE FEMUR LOOSENING, INDICATED FEMUR FIXED TO BONE AND NO LOOSENING REPORTED. COMPLAINT UPDATED ON: OCT 17, 2017.

  Patient problems: Pain

  MAUDE report 6959319 ↗