SIGMA 1024-52-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295002376), received between Feb 8, 2018 and Aug 1, 2023 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT MEDIAL DEPUY HP PARTIAL UNI. INITIALLY PATIENT DID REALLY WELL WITH THIS CONSTRUCT. MORE RECENTLY PATIENT HAS HAD PAIN IN THE KNEE. PATIENT ELECTED TO CONVERT THE UNI TO A TOTAL KNEE. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17434011 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT MEDIAL UKA REVISION FOR PAIN AND OSTEOARTHRITIS. DOI: (B)(6) 2020, DOR: (B)(6) 2023, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16643210 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO ALLEGE PRODUCT DEFICIENCY. THE PATIENT JUST FELL.

  Patient problems: Bone Fracture(s); Fall; Pain

  MAUDE report 13043655 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND BROKE HER PROXIMAL TIBIA SO DOCTOR TOOK OUT UNI KNEE AND PUT IN TOTAL KNEE DOI: (B)(6) 2021. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 12103661 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIGMA PARTIAL KNEE REVISION.

  Patient problems: Pain

  MAUDE report 11453957 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REPLACE UNI FEMUR, UNI TIBIA, AND UNI INSERT BECAUSE KNEE WAS UNSTABLE. DOI: (B)(6) 2016; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9711826 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PAINFUL RIGHT KNEE. IMPLANTS REMOVED AND REVISED TO TOTAL.

  Patient problems: No Code Available; Pain

  MAUDE report 7980605 ↗
• InjuryFeb 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED DUE TO TIBIAL PLATEAU FRACTURE. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Bone Fracture(s)

  MAUDE report 7251244 ↗