NA 1011-06-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295000372), received between Jun 17, 2022 and Jun 17, 2022 — classified as 2 injuries.

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.

• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PC WAS CREATED TO CAPTURE THE EVENT. (PG 2560) (B)(6) 2009 OPERATIVE RECORDS INDICATE THE PATIENT RECEIVED A LEFT TOTAL HIP REVISION DUE TO SIGNIFICANT SCARRING AND GROSS INFECTION. ACETABULAR CAGE AND PROSTALAC WAS REMOVED AND IRRIGATION AND DEBRIDEMENT WAS PERFORMED. DOI: (B)(6) 2009, DOR: (B)(6) 2009, LEFT HIP.

  Patient problems: Adhesion(s); Scar Tissue; Unspecified Infection

  MAUDE report 14732255 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PC WAS CREATED TO CAPTURE THE EVENT. (PG 2560) (B)(6) 2009 OPERATIVE RECORDS INDICATE THE PATIENT RECEIVED A LEFT TOTAL HIP REVISION DUE TO SIGNIFICANT SCARRING AND GROSS INFECTION. ACETABULAR CAGE AND PROSTALAC WAS REMOVED AND IRRIGATION AND DEBRIDEMENT WAS PERFORMED. DOI: (B)(6) 2009. DOR: (B)(6) 2009. LEFT HIP.

  Patient problems: Adhesion(s); Scar Tissue; Unspecified Infection

  MAUDE report 14732249 ↗