CPCS 71312416Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010467010), received between May 21, 2021 and May 21, 2021 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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.

• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR PERFORMED IN (B)(6) 2013, AS A REVISION SURGERY FOR INFECTION OF NON SMITH AND NEPHEW DEVICES, THE PATIENT EXPERIENCED PAIN IN THE RIGHT HIP AND A POSSIBLE RECURRENT INFECTION WAS SUSPECTED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THESE ADVERSE EVENTS. THE OXINIUM FEM HD 12/14 36 MM +0 ((B)(4)), THE R3 20 DEG XLPE ACET LNR 36MM X 60MM ((B)(4)), THE CPCS COCR PRIM HO 12/14 SZ 5 ((B)(4)), AND THE CPCS DIST CENT SZ 16MM ((B)(4)) WERE EXPLANTED. IT IS UNKNOWN WHICH NEW DEVICES WERE IMPLANTED. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11861836 ↗