SIGMA 96-2322Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295242055), received between Apr 30, 2018 and Jul 11, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 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 PAINFUL KNEE. THERE WAS NO LOOSENING. DOI: UNKNOWN . DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 17298832 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TOTAL KNEE EXPLANT WAS PERFORMED DUE TO KNEE JOINT INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014. DOR: (B)(6) 2014. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15983805 ↗
• InjuryApr 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT WAS EXPERIENCING SOME MILD DISCOMFORT WITH HER LEFT TOTAL KNEE WITH DEPUY TC3/MBT REVISION STYLE COMPONENTS. THE LEFT KNEE WAS ASPIRATED AND DETERMINED NOT TO BE INFECTED. THE KNEE WAS SURGICALLY OPERATED AND EXPLORED. THE SURGEON DETERMINED THAT NONE OF THE COMPONENTS WERE LOOSE. THE POLYETHELYENE TIBIAL INSERT WAS REMOVED TO ATTAIN BETTER SURGICAL EXPOSURE AND ACCESS TO THE POSTERIOR SOFT TISSUE. IT WAS DETERMINED FROM TRAILING THAT THE FINAL TIBIAL INSERT SHOULD BE INCREASED FROM A 12.5MM TO 17MM THICKNESS. DOI:UNKNOWN DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Discomfort; Not Applicable

  MAUDE report 7472461 ↗