SIGMA 96-2321Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295242048), received between Sep 8, 2017 and Jan 11, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS LOOSE IN EXTENSION, LEADING TO DECREASED STABILITY. PHYSICIAN REMOVED THE OLD POLY AND UPSIZED FOR BETTER STABILITY. (B)(6). AFFECTED SIDE: RIGHT KNEE

  Patient problems: Joint Laxity

  MAUDE report 18491545 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO KNOWN INFECTION. I& D W POLY EXCHANGE PERFORMED. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12979023 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10683835 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2018. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9204170 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. IT IS INDICATED THE PATIENT WAS EXPERIENCING PAIN PRIOR TO REVISION ON 6/10/2019. ALSO, THE SURGEON NOTED THE PATIENT EXPERIENCED EXPECTED ACUTE BLOOD LOSS ANEMIA POST-OPERATIVELY AND RECEIVED TWO UNITS OF PACKED RED BLOOD CELLS TO ADDRESS THE ISSUE.

  Patient problems: Joint Disorder; No Code Available; Pain

  MAUDE report 8982808 ↗
• InjurySep 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6852310 ↗