NA 74222200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010552518), received between Jun 10, 2020 and Jul 30, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION HIP SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO ELEVATED HIP EFFUSION. ALSO, SERUM COBALT BLOOD WORK REPORT FROM SHOWED ELEVATED COBALT AND CHROMIUM LEVEL. THE MODULAR METAL HEAD, THE SLEEVE AND THE R3 METAL LINER WERE EXPLANTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10347411 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING REVISION SURGERY, THE MODULAR SLEEVE WAS REMOVED FROM THE PATIENT DUE TO AN UNSPECIFIED REASON. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury; No Code Available; Osteolysis

  MAUDE report 10136939 ↗