R3 ACETABULAR 71331860Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010597632), received between Feb 5, 2021 and Feb 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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.

• MalfunctionFeb 5, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING UNKNOWN PROCEDURE THE CUP SEAL SEEMED TO BE DAMAGED AND IT WAS NECESSARY TO TAKE OFF THE FIELD AND SWITCH IMPLANTS. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS THAN OR EQUAL TO 30MIN USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11284610 ↗