NA 1011-71-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295000532), received between Nov 7, 2018 and Apr 25, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2024Osseointegration Problem; Osseointegration Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: ACETABULAR CAGE LOOSE AND PAIN. AT REVISION FRETTING IS NOTED ON THE FEMORAL HEAD AND THERE IS SEVERE YELLOWING OF THE ACETABULAR LINER.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19181179 ↗
• InjuryMar 13, 2020Fracture; Fracture

  THE LITERATURE ARTICLE ENTITLED, "THE EVOLUTION OF THE CUP-CAGE TECHNIQUE FOR MAJOR ACETABULAR DEFECTS FULL AND HALF CUP-CAGE RECONSTRUCTION" WRITTEN BY PETER K. SCULCO, MD, CAMERON K. LEDFORD, MD, ARLEN D. HANSSEN, MD, MATTHEW P. ABDEL, MD AND DAVID G. LEWALLEN, MD PUBLISHED BY THE JOURNAL OF BONE AND JOINT SURGERY 2017 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO REPORT ON THE RESULTS OF UTILIZING CUP-CAGE TECHNIQUE FOR MAJOR ACETABULAR DEFECTS. NON-DEPUY ACETABULAR SHELLS WERE USED IN CONJUNCTION WITH DEPUY PROTRUSIO CAGES AND NON DEPUY JOINT RECONSTRUCTION CAGES. DATA WAS COMPILED FROM 57 CASES. TABLE III PROVIDES PATIENT IDENTIFIERS AND ADVERSE EVENTS BUT NOT IDENTIFY IF PRODUCTS INVOLVED WERE DEPUY OR NON DEPUY. DEPUY PRODUCT: PROTRUSIO CAGE. ADVERSE EVENTS: SCIATIC NERVE INJURY (TREATED BY REOPERATION) HEMATOMA (TREATED BY OPEARTIVE EVACUATION) CAGE/CUP CONSTRUCT LOOSENING (TREATED BY REVISION - SEE FIGURE 5A-5B) RECURRENT INSTABILITY ACCOMPANIED BY DISLOCATION (TREATED BY REVISION).

  Patient problems: Hematoma; No Code Available

  MAUDE report 9832126 ↗
• InjuryFeb 19, 2019Fracture; Fracture

  IT WAS REPORTED THAT HE PROTRUSIO CAGE BROKE AND WAS REMOVED. DUE TO SIGNIFICANT BONE LOSS, ALL COMPONENTS WERE REMOVED AND GIRDLE STONE WAS PERFORMED. IT WAS ALSO REPORTED THAT THERE WAS LOOSENING AT BONE TO IMPLANT INTERFACE BUT IT WAS NOT INDICATED WHICH COMPONENT WAS LOOSE. DOI: (B)(6) 2016; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Injury; No Code Available

  MAUDE report 8351234 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8047660 ↗