NA 1014-68-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295001263), received between Nov 8, 2017 and Jul 6, 2020 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL HIP. REMOVED CUP, HEAD, LINER AND REVISED TO DEPUY MULTIHOLE CUP, HEAD AND LINER. ORIGINAL IMPLANT DATE IS UNKNOWN SO IS ORIGINAL HOSPITAL. DOI: UNKNOWN; DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10236167 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO HIP PAIN. DOI: (B)(6) 2002, DOR: (B)(6) 2020, AFFECTED SITE: UNKNOWN.

  Patient problems: No Code Available; Pain

  MAUDE report 10201032 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS HIP WAS SLIGHTLY UNSTABLE, SO THE SURGEON CHANGED TO A 36 HEAD TO INCREASE STABILITY. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9842970 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8297070 ↗
• InjuryNov 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8105622 ↗
• InjuryAug 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES DISCOMFORT, ASYMMETRIC WEAR AND INSTABILITY. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY PATIENT WAS REVISED DUE TO FAILED ACETABULAR COMPONENT. REVISION NOTES REPORTED OF LARGE AMOUNT OF SCAR TISSUE , OSTEOLYSIS, 2 PERIPHERAL SCREWS WERE REMOVED, AND FOUND THE CUP TO BE LOOSE. CLINICAL VISITS REPORTED OF LOOSE ACETABULAR CUP, AND OSTEOLYTIC DEFECT. DOI: (B)(6) 2004; DOR: (B)(6) 2005; (LEFT HIP).

  Patient problems: Discomfort; Necrosis; Not Applicable; Osteolysis; Scar Tissue

  MAUDE report 7796963 ↗
• InjuryMay 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATES ORIGINAL SURGERY DONE AT ANOTHER HOSPITAL AND NO RECORDS. IN (B)(6) 2017, PATIENT HAD REVISION BY SURGEON FOR HEAD AND LINER EXCHANGE. PATIENT DISLOCATING AND SURGEON REMOVING CUP AND REVISING TO ANOTHER COMPANY. SURGEON KEEPING PT ORIGINAL AML LG TAPER STEM. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7554035 ↗
• InjuryNov 8, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 7008796 ↗