ELITE PLUS 9651-28-043Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295318538), received between Jan 4, 2018 and Sep 10, 2018 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionSep 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2013. IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED TO BE PERFORMED (DATE OF REVISION SURGERY WAS NOT FIXED YET) BY REPLACING THE CUP AND THE HEAD DUE TO DISLOCATION. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 7859440 ↗
• InjuryAug 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE REVISIONS SURGERY WAS PERFORMED ON (B)(6) 2018 (DATE OF THE PRIMARY SURGERY WAS UNKNOWN) BY REPLACING THE STEM, THE HEAD, AND THE CUP DUE TO FREQUENT DISLOCATION. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 7757585 ↗
• 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 7395222 ↗
• InjuryJan 4, 2018Loss of or Failure to Bond; Migration or Expulsion of Device; Loss of or Failure to Bond; Migration or Expulsion of Device

  DER STATES THAT THE PATIENT HAD A TOTAL HIP DONE 2005 IN (B)(4), PRESENTS TODAY WITH A CEMENTED LINER THAT SPUN OUT. WE WERE REQUESTED TO HAVE 12/14 TAPER HEADS. ONCE PATIENT'S FEMORAL HEAD WAS REMOVED THE SURGEON CHECKED TO SEE IF THE 12/14 ARTICUL EZE WOULD FIT, IT DID NOT. IT WAS LOOSE ON TRUNNION AND WOULD NOT ENGAGE AT ALL. THE SURGEON TRIED OTHER 12/14 HEADS AND FOUND ZIMMER 12/14 HEAD FIT VERY WELL, AND WAS SELECTED AS THE NEXT IMPLANT. DOI: 2005; DOE: (B)(6) 2017; UNKNOWN AFFECTED SIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7163324 ↗