ELITE 9625-73-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295243168), received between Sep 1, 2017 and Apr 1, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE DISLOCATION WHICH OCCURRED AFTER THE FIRST SURGERY. THIS PC REPORTS ABOUT THE EVENT WHICH OCCURRED IN THE REDUCTION. IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT THE PRIMARY THA SURGERY FOR OA WITH THE STEM AND THE HEAD IN QUESTION AT (B)(6) HOSPITAL. THE COMPETITORS¿ TRILOGY CUP AND THE LINER WERE COMBINED IMPLANTED. AFTER THE SURGERY, THE PATIENT HAD A DISLOCATION ON AN UNKNOWN DATE. DURING THE REDUCE, THE STEM AND THE HEAD WERE COME OFF. THE DISLODGEMENT WAS NOTICED AFTER THE REDUCTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. DOI: (B)(6) 2010; DOR: (B)(6) 2022; UNKNOWN HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 13976243 ↗
• InjuryMar 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE EVENT WHICH OCCURRED IN THE REDUCTION. THIS PC REPORTS ABOUT THE DISLOCATION WHICH OCCURRED AFTER THE FIRST SURGERY. IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT THE PRIMARY THA SURGERY FOR OA WITH THE STEM AND THE HEAD IN QUESTION. THE TRILOGY CUP AND THE LINER OF ANOTHER COMPANY PRODUCTS WERE COMBINED IMPLANTED. AFTER THE SURGERY, THE PATIENT HAD A DISLOCATION ON AN UNKNOWN DATE. THE REDUCTION OF DISLOCATION WAS PERFORMED ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13840567 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 13366197 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT THE THA SURGERY FOR LEFT OA WITH THE STEM AND HEAD. ON AN UNKNOWN DATE, THE PATIENT REPORTED PAIN AND VISITED THE HOSPITAL. THE PAIN CAUSE WAS SCIATICA, BUT THE X-RAYS SHOWED THAT THE OSTEOLYSIS AND ATROPHY OF THE PROXIMAL LATERAL FEMUR WERE OBSERVED. IN OCTOBER, THE REVISION SURGERY WILL BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 12624271 ↗
• InjuryJul 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION RIGHT TOTAL HIP REPLACEMENT. PATIENT HAD A REVISION SURGERY ON THE (B)(6) 2020 TO REPLACE A LIPPED DURALOC LINER WITH A CONSTRAINED DURALOC LINER DUE TO DISLOCATION. PATIENT HAS SUBSEQUENTLY DISLOCATED FROM THE CONSTRAINED LINER. SURGEON DECIDED TO REMOVE DURALOC SIZE 54 CUP, ID28 OD54 CONSTRAINED LINER AND 9-10TAPER SIZE 28 ELITE HEAD AND REPLACE IT WITH SIZE 56 PINNACLE MULTIHOLE CUP, ID32 OD 56 PINNACLE CONSTRAINED LINER AND A SIZE 32 9-10 TAPER HEAD. ACCORDING TO THE SURGEON THE PATIENT SLIPPED AND DISLOCATED HER HIP.

  Patient problems: Fall; Joint Dislocation; No Code Available

  MAUDE report 10344140 ↗
• InjuryJun 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE SURGEON COMMENTED THAT THE SOFT TISSUE ENVELOPED AROUND THE HIP WAS NOT CONSTRAINED DUE TO THE LENGTH OF THE TIME THE PREVIOUS IMPLANTS HAVE BEEN IN SITU.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10116506 ↗
• InjuryApr 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2009 VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED (DATE OF THE REVISION WAS UNKNOWN) BY REPLACING THE CUP AND HEAD DUE TO THE PAIN. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. DOI: (B)(6) 2009; DOR:UNKNOWN; UNKNOWN HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7395231 ↗
• InjuryJan 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT THR, DR (B)(6), (B)(6) HOSPITAL (B)(6) 2017. PRIMARY IMPLANT (B)(6) 2003 - (B)(6) HOSPITAL, DR (B)(6). REVISION FOR PAIN. FEMALE PATIENT INITIALS (B)(6). DOI:2003; DOR:(B)(6) 2017; RIGHT HIP.

  Patient problems: Osteolysis; Pain

  MAUDE report 7160589 ↗
• InjurySep 1, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DUE TO DISLOCATION. UPDATE 8/3/2017. IT IS NOTED WITHIN THE ADDITIONAL INFORMATION THAT A CUP WITH SCREWS WAS ALSO REVISED IN THIS REVISION SURGERY. NO PART AND LOT WERE PROVIDED BUT IT APPEARS THAT IT MAY HAVE BEEN A COMPETITOR CUP AND SCREWS (MAH: KYOCERA)--ADDITIONAL PRODUCT FOLLOW-UP IS BEING INITIATED TO CLARIFY. FURTHER REPORTING MAY FOLLOW BASED UPON ANY INFORMATION RETRIEVED. CURRENTLY, THERE IS NOT ENOUGH INFORMATION TO DETERMINE IF THESE PRODUCTS WERE SOLD IN THE US. COMPLAINT UPDATED ON: 9/1/2017.

  Patient problems: Joint Dislocation

  MAUDE report 6838292 ↗