NA 1172-15-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295007593), received between Mar 6, 2018 and Sep 5, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2003, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA THA ON HIP JOINT WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IN EARLY 2025, THE INFECTED AREA WAS CLEANED BY DEBRIDEMENT, BUT THE CONDITION WAS NOT COMPLETELY CURED. SURGEON DECIDED AGAINST COMPLETE REMOVAL FOR THE TIME BEING, AND BECAUSE THE LINER WAS WORN, HE SAID HE WOULD MONITOR THE SITUATION AND CONSIDER REPLACING THE LINER.

  Patient problems: Unspecified Infection

  MAUDE report 22979363 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2000, THE PRIMARY SURGERY WAS PERFORMED VIA THA WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY, THE PATIENT REPEATEDLY DISLOCATED. THE EVENT DATE IS UNKNOWN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, TO REMOVE THE STEM, THE LINER AND THE SCREWS OF THE CUP. AFTER THE TRIAL, THE LINER, THE STEM AND THE HEAD WAS REPLACED. THE REASON FOR THE REVISION IS DISLOCATION DUE TO IMPINGEMENT. DOI: (B)(6) 2000. DOR: (B)(6) 2023. UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 17689353 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2004, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA FOR RIGHT OA WITH THE AML-PLUS AND DURALOC IMPLANTS IN QUESTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS DOING WELL FOR SOME TIME. THEN, THE PATIENT COMPLAINED OF DISCOMFORT, AND BECAUSE OF EXAMINATION, INFECTION WAS FOUND ON (B)(6) 2022. A REVISION SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2004; DOR: (B)(6) 2022; RIGHT HIP.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 15731758 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 TRUNNIONOSIS, 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 11568050 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 11568036 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN. THE SURGEON COMMENTED THAT THE PAIN SEEMED TO BE CAUSED BY THE TRUNNION, BUT THE TAPER OF THE NECK AND HEAD WAS UNEXPECTEDLY CLEAN.

  Patient problems: Pain

  MAUDE report 11398067 ↗
• 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 TRUNNIONOSIS, 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 11398066 ↗
• MalfunctionSep 9, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE AT (B)(6) HOSPITAL. THE 1ST REVISION SURGERY WAS PERFORMED ON (B)(6) AT (B)(6) HOSPITAL. WHEN THE 1ST REVISION SURGERY, THE SURGEON PERFORMED GREAT TROCHANTER OSTEOTOMY AND JOINTED WITH A GREAT TROCHANTER GRIP, HOWEVER, THERE WAS A SUSPICION OF JOINT FAILURE. AND, THERE WAS ALSO SUSPICION OF LOOSENING OF THE CUP, THE PATIENT HAD BEEN UNDER FOLLOW-UP BY THE SURGEON. IT WAS REPORTED THAT THE PATIENT HAD A PAIN IN EARLY (B)(6) 2020, AND THE SURGEON CONFIRMED THE DISLOCATION OF THE HEAD FROM THE STEM¿S NECK BY X-RAY. THERE WAS NO CAUSE OF THE DISLOCATION LIKE IMPACT SHOCK. THE SURGEON THOUGHT THAT THE CORROSION OF NECK TRUNNION POINT CAUSED THE DISLOCATION. THE PATIENT CANNOT WALK DUE TO THE DISLOCATION. THE SURGEON PLANNED 2ND REVISION SURGERY BY REPLACING THE HEAD IF HE CAN HAVE HIS DESIRED IMPLANT, BUT IF THE IMPLANT CANNOT BE ENGAGED, HE WILL CONTINUE FOLLOW-UP FOR THE PATIENT BECAUSE REMOVING THE STEM CAUSES AN EXTENSIVE INVASIVE SURGERY FOR ADVANCED OLD AGE PATIENT AS (B)(6) YEARS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10511626 ↗
• InjuryMay 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  DER STATED THAT PRIMARY THA WAS DONE IN 2003 (EXACT DATE UNKNOWN). HEAD-ON AUTOMOBILE COLLISION IN (B)(6) 2017 LED TO CHRONIC DISLOCATION OF IMPLANT, REQUIRING ACETABULAR REVISION. CUP, LINER, AND HEAD WERE REVISED. CUP WAS LOOSE AT THE BONE TO IMPLANT INTERFACE. DOI: 2003; DOR (B)(6) 2018; RIGHT HIP. NO SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7507598 ↗
• 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 7316802 ↗
• InjuryMar 6, 2018Failure To Adhere Or Bond; Failure To Adhere Or 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 7316800 ↗