NA 1521-90-053Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295276586), received between Feb 13, 2018 and Aug 28, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50504446 ↗
• InjuryAug 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT THE TOTAL HIP ARTHROPLASTY WITH THE LINER, THE APEX HOLE ELIMINATOR, THE DURALOC, THE AML, AND THE HEAD FOR THE LEFT HIP JOINT AT (B)(6) HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, FREQUENT DISLOCATION OCCURRED, SO THAT THE PATIENT VISITED (B)(6) HOSPITAL. ON (B)(6) 2022, THE PATIENT UNDERWENT THE REVISION SURGERY. THE CUP, THE LINER, AND THE HEAD WERE REMOVED, AND THE CUP WAS REPLACED WITH ZIMMER BIOMET¿S CUP. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2009; DOR: (B)(6) 2022; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15311935 ↗
• InjuryJul 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED IN (B)(6) 2006 (THE DATE WAS UNKNOWN) VIA THA AT ANOTHER HOSPITAL. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE HEAD AND THE LINER BECAUSE THE HEAD DISLOCATED FROM THE STEM AND THE PATIENT HAD A DIFFICULTY IN WALKING. THE SURGEON REPLACED THE HEAD WITH A 26MM HEAD. THE REVISION SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; No Code Available

  MAUDE report 10344378 ↗
• InjuryAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PRIMARY SURGERY WAS PERFORMED ON SEVERAL YEARS AGO (DATE OF THE PRIMARY SURGERY WAS UNKNOWN). IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 BY REPLACING THE HEAD DUE TO ARMD. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Tissue Damage

  MAUDE report 7767708 ↗
• InjuryFeb 13, 2018Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated

  THE THA WAS PERFORMED TO THE PATIENT ON (B)(6) 2006. AFTER THE SURGERY, THE INNER HEAD WAS DETACHED BECAUSE THE DISLOCATED WAS OCCURRED WHEN THE PATIENT FELL DOWN FROM THE CHAIR. UNTIL THEN, THE PATIENT NEVER HAD A DISLOCATION. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 BY REPLACING THE CUP AND THE HEAD. THERE WAS LITTLE DENATURATION AT THE JUNCTION, A SMALL AMOUNT OF BLACK DEBRIS WAS OBSERVED, AND SOFT TISSUE NECROSIS WAS NOT OBSERVED. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 7266090 ↗