NA 1172-20-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295007609), received between May 11, 2018 and Mar 2, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 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 24489997 ↗
• 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 15732468 ↗
• 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 OCT. 19, 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 15731320 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE SCREWS, THE LINER, THE STEM, AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS INFECTED. THEREFORE, A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2022. THE IMPLANTS WILL BE DISCARDED, SO THAT THEY WILL NOT BE RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15241824 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE SCREWS, THE LINER, THE STEM, AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS INFECTED. THEREFORE, A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2022. THE IMPLANTS WILL BE DISCARDED, SO THAT THEY WILL NOT BE RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15241769 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE SCREWS, THE LINER, THE STEM, AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS INFECTED. THEREFORE, A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2022. THE IMPLANTS WILL BE DISCARDED, SO THAT THEY WILL NOT BE RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15241672 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL REPORT THAT ON (B)(6) 1997, THE PRIMARY SURGERY WAS PERFORMED VIA THA WITH THE IMPLANTS. ON AN UNKNOWN DATE, THE PATIENT REPORTED PAIN AND VISITED THE HOSPITAL. THE REVISION SURGERY WAS PLANNED TO BE PERFORMED IN THE FUTURE. FOLLOW UP PROVIDES FURTHER INFORMATION THAT THE REVISION WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 11930899 ↗
• 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 (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). NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 10511604 ↗
• InjuryMay 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED A X-RAY OF A POST THR PATIENT, SEEMS A BROCKEN STEM FROM THE NECK AND LOOKS JNJ CORAIL PINNACLE PRODUCT. PATIENT WAS COMPLAINING SEVERE PAIN IN RIGHT SIDE OF HIP, INABILITY TO STAND AND INABILITY TO WALK. PATIENT ALSO INFORMED SURGEON THAT HE GOT FALLEN DURING HIS ROUTINE WORK. PATIENT ALSO INFORMED TO SURGEON THAT HIS RIGHT HIP WAS ALREADY OPERATED IN 2018 DUE TO AVN BY ANY OTHER SURGEON FROM THE PATNA, & RT HIP WAS IMPLANTED WITH JNJ PRODUCT. AND PATIENT HAS ALSO REPORTED THAT HE IS HAVING PAIN IN HIS RT HIP (OPERATED SITE) AND GETTING SOME UNUSUAL SOUND SINCE LAST ONE YEAR.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10022555 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE VIA THA. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2020 BY REMOVING THE CUP (P/N: 124552000) AND THE LINER (P/N: 124052000) DUE TO POSTOPERATIVE INFECTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9954743 ↗
• InjuryJan 30, 2020Loss of Osseointegration; Loss of Osseointegration

  ADDITIONAL INFORMATION RECEIVED INDICATING: THE PATIENT HAS HAD HIP OSTEOTOMY IN THE PAST, THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2004 VIA THA FOR THE RIGHT HIP JOINT. SINCE THE ACETABULAR WEAR WAS REMARKABLE, THE REVISION SURGERY WAS PERFORMED AS SCHEDULED. ALL IMPLANTS ON THE ACETABULAR SIDE WERE EXPLANTED, ALLOGRAFT, ARTIFICIAL BONE AND METAL MESH WERE TRANSPLANTED, A CEMENTED CUP WAS FIXED. THE STEM WAS RETAINED. THE POLY LINER WAS WORN OUT ENOUGH TO BE VISUALLY RECOGNIZED BY X-RAY.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9647802 ↗
• InjuryJan 4, 2019Biocompatibility; Biocompatibility

  REVISION DUE TO PAIN AND ELEVATED METAL IONS.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8217310 ↗
• InjuryDec 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO PAIN.

  Patient problems: Hearing Loss; Loss of Vision; Memory Loss/Impairment; Pain

  MAUDE report 8167485 ↗
• InjuryDec 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  (B)(6) COMMUNICATED FOR COMPLAINT OF HIS WIFE (B)(6) FOR JNJ DEPUY PRODUCT. BOTH HIP REPLACEMENT SURGERY AND THEN REVISION SURGERY IN MAX HOSPITAL. 3RD SURGERY GRIDLE SURGERY TO REMOVE DEPUY (JNJ) DEFECTIVE .

  Patient problems: Hearing Loss; Loss of Vision; Memory Loss/Impairment; Pain

  MAUDE report 8167482 ↗
• 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 7507563 ↗