NA 1521-90-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295276654), received between Apr 3, 2018 and Aug 6, 2024 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA FOR THE LEFT HIP JOINT WITH THE IMPLANTS IN QUESTION. ON (B)(6) 2024, DUE TO AGE-RELATED DETERIORATION, THE SLIDING SURFACES OF THE ACETABULAR IMPLANT AND STEM HEAD WERE REPLACED. DUE TO THE EXTENSIVE PSEUDOTUMOR, THE IMPLANTS WERE REMOVED AND REPLACED WITH IMPLANTS MADE BY ANOTHER COMPANY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19917492 ↗
• InjuryDec 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA WITH THE LINER IN QUESTION. ON AN UNKNOWN DATE, IT WAS CONFIRMED THE LINER IN QUESTION WAS WORN OUT. THEREFORE, REVISION SURGERY WILL BE SCHEDULED ON (B)(6) 2023. ONLY THE LINER WILL BE REPLACED, BUT THE CUP AND STEM WILL ALSO BE REPLACED DEPENDING ON THE STATUS OF THE OTHER IMPLANTS. IF ONLY THE LINER AND HEAD ARE REPLACED, USE JJ PRODUCT IMPLANTS; IF THE REPLACEMENT EXTENDS TO THE CUP AND STEM, USE PRODUCTS MADE BY ANOTHER COMPANY (ZB). IT IS UNKNOWN WHETHER THE IMPLANTS OTHER THAN REPORTED PRODUCTS USED IN THE PRIMARY SURGERY ARE JJ PRODUCTS OR NOT. NO FURTHER INFORMATION IS AVAILABLE. NEW INFORMATION WAS RECEIVED FROM SALES REP ON DEC 21,2023 AS FOLLOWS: THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2002, AT ANOTHER HOSPITAL. THERE WAS WEAR OF THE POLYETHYLENE OVER TIME, BUT THE FINAL REASON FOR THE REVISION SURGERY WAS HEAD-NECK JUNCTION FAILURE SINCE THE METAL HEAD WAS DE-ROTATED FROM THE AML PLUS STEM. THIS IS ALL THAT IS KNOWN ABOUT THE CURRENT SITUATION BEFORE REVISION SURGERY IS PERFORMED. NEW INFORMATION RECEIVED FROM THE SALES REP ON DEC 28, 2023 AS FOLLOWS: REVISION SURGERY WAS PERFORMED ON (B)(6) 202

  Patient problems: Insufficient Information

  MAUDE report 18415475 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED WITH THE CUP AND THE IMPLANT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, TO REMOVE THE IMPLANTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16709159 ↗
• InjuryMar 22, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2005, THE PATIENT UNDERWENT THE PRIMARY SURGERY FOR LEFT HIP JOINT VIA THA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, ARMD AND IMPLANTS LOOSENING WERE CONFIRMED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE LINER IN QUESTION WAS REPLACED TO THE SAME SIZE AND THE TOTAL IMPLANTS ON THE FEMORAL SIDE WERE REMOVED AND REPLACED TO ARTIFICIAL JOINTS BY ZB. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT ARMD WAS THE CAUSE OF THE LOOSENING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 16591535 ↗
• InjuryJul 12, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, ON (B)(6) 2022, A REMOVAL SURGERY FOR A PSEUDOTUMOR OF THE INGUINAL REMOVAL SURGERY WILL BE PERFORMED DUE TO ARMD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Dislocation; Swelling/ Edema

  MAUDE report 14990454 ↗
• InjuryMar 22, 2021Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED IN (B)(6) 2007. ON (B)(6) 2021, THE PATIENT UNDERWENT THE REVISION SURGERY DUE TO THE REPEATED DISLOCATION. THE SURGEON COMMENTED THAT THERE WERE BLACK DEPOSITS IN THE NECK TAPER AND HEAD. DOI: (B)(6) 2007. DOR: (B)(6) 2021; UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11543614 ↗
• InjuryJun 11, 2020Degraded; Device-Device Incompatibility; Device Dislodged or Dislocated; Degraded; Device-Device Incompatibility; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY IN WALKING BECAUSE THE HEAD (P/N: 152190060) POPPED OUT OF THE NECK. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE HEAD AND THE CUP (P/N: UNKNOWN). IN VIEW OF THE HEAD¿S POPPING OUT OF THE NECK, THERE WAS A SUSPICION OF CORROSION. THE REVISION SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; No Code Available

  MAUDE report 10145107 ↗
• InjuryApr 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED ON SOMEDAY BETWEEN 2010 AND 2011 VIA THA AT ANOTHER HOSPITAL ((B)(6) MEDICAL CENTER). IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020 DUE TO FREQUENT DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9959269 ↗
• InjuryMar 4, 2019Corroded; Corroded

  REVISION DUE TO LOOSEN OF THE STEM CAUSED BY CORROSION OF THE HEAD-NECK JUNCTION.

  Patient problems: No Code Available

  MAUDE report 8386046 ↗
• InjuryJul 31, 2018Separation Problem; Separation Problem

  LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Fall

  MAUDE report 7735410 ↗
• InjuryJun 1, 2018Naturally Worn; Naturally Worn

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2004. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 DUE TO THE LINER WORN OFF BY REPLACING THE CUP, THE STEM AND THE LINER. AFTER THE SURGERY, THE SURGEON FOUND THAT THERE WERE BLACK PARTICLES AROUND THE STEM NECK. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. DOI: (B)(6) 2004; DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

  Patient problems: Not Applicable

  MAUDE report 7561081 ↗
• InjuryApr 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PRIMARY SURGERY WAS PERFORMED VIA THA (DATE OF IMPLANT WAS UNKNOWN). AFTER THE PRIMARY SURGERY, THE PATIENT COMPLAINED THE PAIN, AND VISITED TO THE HOSPITAL. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 BY REPLACING TO ANOTHER MANUFACTURER¿S IMPLANTS. DURING THE SURGERY, THE SURGEON NOTICED THAT THE HEAD EASILY DETACHED BY HAND, AND THE HEAD TRIAL WAS NOT FIXED AT ALL. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Pain

  MAUDE report 7391815 ↗