SIGMA 96-2368Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295242581), received between Jun 19, 2018 and May 26, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A SECOND RIGHT KNEE REVISION TO ADDRESS INFECTION, WOUND DEHISCENCE, DELAYED WOUND HEALING, DRAINAGE, AND MILD REDNESS AROUND WOUND. THE TIBIAL INSERT WAS THE ONLY PRODUCT REVISED. THE SURGEON ALSO PERFORMED AN IRRIGATION AND DEBRIDEMENT, PLACEMENT OF ANTIBIOTIC CONTAINING PELLETS, CLOSURE OF PREVIOUS LATERAL RELEASE, SCAR REVISION LATERAL WOUND 5 CM, AND REPAIR OF PARTIAL PATELLAR TENDON AVULSION USING TWO SUTURES. THE SURGEON NOTED THE PREVIOUS PATELLAR TENDON REPAIR WAS INTACT, HOWEVER, THERE WAS NO WAY HE COULD GET THE KNEE FLEXED UP ENOUGH TO REMOVE THE TIBIAL INSERT. THEREFORE, THE REPAIR WAS TAKEN DOWN TO ALLOW REMOVAL OF TIBIAL INSERT. MOST OF THE PATELLAR TENDON HAD PREVIOUSLY STAYED INTACT. HOWEVER, THERE WAS SIGNIFICANT AVULSION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erythema; Fluid Discharge; Impaired Healing; Muscle/Tendon Damage; Pain; Wound Dehiscence

  MAUDE report 11891658 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 10986265 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I & D WITH POLY SWAP WAS DONE DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9765514 ↗
• InjuryJun 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PRIMARY LEFT KNEE WAS REVISED FOR INFECTION. ANTIBIOTIC SPACER WAS IMPLANTED FOR SEVERAL MONTHS. SECOND-STAGE REVISION COMPLETED ON THE (B)(6) 2018. THE 3RD REVISION (B)(6) 2018 ELEVATED CRP LEVELS AND OTHER SIGNS OF INFECTION. PATIENT REPORTED TO HAVE HAD A MECHANICAL FALL TWO WEEKS POST-OPERATIVE. PATIENT LANDED ON LEFT KNEE. MALE PATIENT ID: (B)(6), AGED (B)(6) YEARS, DOB: (B)(6). .

  Patient problems: Fall; Not Applicable; Unspecified Infection

  MAUDE report 7613769 ↗