NA 1172-35-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295007630), received between Mar 6, 2018 and Mar 2, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THA FOR TRAUMA ON LEFT HIP JOINT WITH THE PRODUCTS IN QUESTION AT AROUND (B)(6) 2007. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. DURING HOSPITALIZATION FOR TREATMENT OF A FRACTURE IN ANOTHER AREA, SIGNIFICANT WEAR WAS FOUND ON THE CUP AND LINER USED IN THE LEFT HIP. THE AFFECTED AREA BY THE FRACTURE WAS NOT THE LEFT HIP, AND THE TREATMENT FOR THE FRACTURE WAS NOT RELATED TO THE LEFT HIP. DUE TO SEVERE BONE LOSS ON THE ACETABULAR SIDE, THE HOSPITAL COULD NOT PERFORM THE SCHEDULED REVISION SURGERY, AND THE PATIENT WILL BE REFERRED TO ANOTHER FACILITY. THE REVISION SCHEDULED FOR (B)(6) WAS CANCELED. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Bone Notching

  MAUDE report 24490008 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THA FOR TRAUMA ON LEFT HIP JOINT WITH THE PRODUCTS IN QUESTION AT AROUND (B)(6) 2007. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. DURING HOSPITALIZATION FOR TREATMENT OF A FRACTURE IN ANOTHER AREA, SIGNIFICANT WEAR WAS FOUND ON THE CUP AND LINER USED IN THE LEFT HIP. THE AFFECTED AREA BY THE FRACTURE WAS NOT THE LEFT HIP, AND THE TREATMENT FOR THE FRACTURE WAS NOT RELATED TO THE LEFT HIP. DUE TO SEVERE BONE LOSS ON THE ACETABULAR SIDE, THE HOSPITAL COULD NOT PERFORM THE SCHEDULED REVISION SURGERY, AND THE PATIENT WILL BE REFERRED TO ANOTHER FACILITY. THE REVISION SCHEDULED FOR (B)(6) WAS CANCELED. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Bone Notching

  MAUDE report 24490000 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2009 FOR THE PATIENT'S HIP JOINT. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE REASON OF THE REVISION SURGERY WAS SUDDEN PAIN. THE SURGEON HAD PREDICTED SOME PROBLEM CAUSED BY TRUNNIONS, HOWEVER, MADE AN INCISION AND LOOKED AT THE AFFECTED AREA, THERE WAS NO METAL DEBRIS AT NECK AND HEAD, NO SIGN OF ARMD. THERE WAS NO LOOSENING. THE SURGEON COMMENTED THAT SURPRISINGLY, IT WAS FINE. HE DID NOT MENTION THE CAUSE OF PAIN. THE SURGEON REMOVED ALL IMPLANTS AND INSERTED NEW IMPLANTS (MANUFACTURED BY ANOTHER COMPANY). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11398068 ↗
• InjuryJul 2, 2020Unintended Movement; Migration; Unintended Movement; Migration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2002 VIA THA FOR THE PATIENT¿S RIGHT HIP JOINT. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE CUP (P/N: 124552000), THE LINER (P/N: 124012000), AND THE HEAD (P/N: 853824) DUE TO ACETABULAR SIDE¿S PAIN AND MIGRATION. A STEM (P/N: UNKNOWN) WAS REMAINED BECAUSE THERE WAS NO REMARK OF DEGENERATION. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE SURGEON THOUGHT THAT ONE OF THE FACTORS WAS INSUFFICIENCY OF REAMING FOR THE CUP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 10224332 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP SUBLUXED MANY TIMES OVER THE PAST COUPLE OF YEARS, BUT LAST WEEK IT FINALLY DISLOCATED COMPLETELY. THEY WERE ABLE TO REDUCE HIM BUT HE DECIDED TO HAVE IT REVISED. NO CORROSION ON THE NECK TAPER AND HEAD JOINT. EVERYTHING WAS WELL FIXED. I DO NOT HAVE THE EXACT DATE THEY WERE ORIGINALLY IMPLANTED IN 2003. DOI: 2003. DOR: (B)(6) 2020; RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 10191088 ↗
• InjuryJan 24, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2000; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9629214 ↗
• InjuryNov 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 8090217 ↗
• InjuryMar 6, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE REPORTED IMPLANTS WERE IMPLANTED TO THE PATIENT ON (B)(6) 2004. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 DUE TO THE LOOSENING OF THE CUP AND POLYETHYLENE PART WAS WORN DOWN. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. DOI: (B)(6) 2004; DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7316833 ↗