UniSyn® Hip System 3422-11619-0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844588008894), received between Jun 3, 2020 and Jun 3, 2020 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PER AESCULAP COMPLAINT REPORT (B)(4): IT WAS REPORTED BY THE LEGAL DEPARTMENT ON 06MAY2020, THAT AS A RESULT OF HAVING AN AESCULAP HIP SYSTEM IMPLANTED, THE PATIENT HAS EXPERIENCED, FRACTURE OF THE FEMORAL STEM, ON APPROXIMATELY (B)(6) 2018 THE PATIENT'S LEFT HIP POPPED AND HE FELL, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED AROUND (B)(6) 2010, AND THE REVISION SURGERY OCCURRED ON, (B)(6) 2019. BASED ON THE INFORMATION PROVIDED THE SURGEON ASSOCIATED WITH THE REPORTED EVENT WAS LISTED AS, DR. (B)(6), AND THE PATIENT ASSOCIATED WITH THE REPORTED EVENT WAS LISTED WITH THE INITIALS OF, (B)(6).

  Patient problems: Missing Value Reason

  MAUDE report 10117159 ↗