NA 1521-90-057Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295276623), received between Nov 5, 2018 and Feb 24, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2007, THE PATIENT UNDERWENT THA WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, OSTEOLYSIS IS OBSERVED DUE TO LINER WEAR. ON (B)(6) 2026, THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE CUP AND SLEEVE ARE RETAINED, AND THE LINER, HEAD, AND STEM WERE REPLACED.

  Patient problems: Osteolysis

  MAUDE report 24430514 ↗
• InjuryJul 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE BREAKAGE OF THE LINER AFTER THE REVISION SURGERY. THIS PC REPORTS DISLOCATION WHICH IS THE REASON FOR THE REVISION SURGERY AFTER THE PRIMARY SURGERY. IT WAS REPORTED THAT ON (B)(6) 2011, THE PRIMARY SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY, THE DISLOCATION WAS CONFIRMED. THE EVENT DATE IS UNKNOWN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2016, TO REPLACE THE LINER, THE HEAD AND THE STEM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 17320973 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2007, THE PATIENT UNDERWENT THE THA SURGERY FOR LEFT HIP WITH STEM IN QUESTION. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. RECENTLY, THE PATIENT COMPLAINED OF DISCOMFORT AROUND THE LEFT HIP JOINT. ON (B)(6) 2022, A REACTIVE PSEUDOTUMOR WAS CONFIRMED AROUND THE LEFT HIP BY IMAGE. THE SURGEON CONSIDERED THAT IT WAS CAUSED BY THE STEM AND HEAD INTERDIGITATION AND PLANNED TO PERFORM REVISION THA ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2007. DOR: (B)(6) 2022; LEFT HIP.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction

  MAUDE report 13384642 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT THA SURGERY 15 YEARS AGO. FOLLOWING SURGERY, PATIENT COMPLAINED OF PAIN. UPON INVESTIGATION, IT WAS CONFIRMED A PERIPROSTHETIC JOINT INFECTION HAD DEVELOPED. REVISION WAS COMPLETED TO ADDRESS THE ISSUE. IMPLANTS WERE REMOVED AND AFFECTED AREA WAS TREATED WITH ANTIBIOTICS. IMPLANTATION OF NEW IMPLANTS WILL OCCUR ONCE INFECTION SUBSIDES.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13215681 ↗
• InjurySep 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 1995, THE PATIENT UNDERWENT THE THA SURGERY WITH THE LINER AND THE HEAD IN QUESTION. AFTER THE SURGERY, ON (B)(6) 2021, THE PATIENT FELL, AND HIS/HER HIP DISLOCATED. ON THE SAME DAY, THE LINER AND THE HEAD WERE REPLACED WITH NEW ONES. DOI: (B)(6) 1995; DOR: (B)(6) 2021; UNKNOWN SIDE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 12431897 ↗
• InjuryJul 2, 2021Off-Label Use; Off-Label Use

  THIS MDR IS RELATED TO THE FOURTH REVISION SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE THA SURGERY WITH UNKNOWN IMPLANTS. ON AN UNKNOWN DATE, THE LOOSENING OF THE IMPLANT OCCURRED, AND THE FIRST REVISION SURGERY WAS PERFORMED. IN THE REVISION, ZIMMER BIOMET PLATE, ZIMMER BIOMET CUP AND SOLUTION PLUS STEM (J&J PRODUCT) WERE IMPLANTED. ON (B)(6) 2017, THE SECOND REVISION SURGERY WAS PERFORMED DUE TO THE IMPLANTS LOOSENING AT ACETABULAR SIDE. IN THE REVISION, ZIMMER BIOMET PLATE, ZIMMER BIOMET CUP AND THE HEAD (J&J PRODUCT) WERE IMPLANTED. ON (B)(6) 2020, THE THIRD REVISION SURGERY WAS PERFORMED DUE TO THE IMPLANTS LOOSENING AT ACETABULAR SIDE. IN THE REVISION, ZIMMER BIOMET AUGMENT, ZIMMER BIOMET PLATE, ZIMMER BIOMET CUP AND THE HEAD (J&J PRODUCT) WERE IMPLANTED. ON (B)(6) 2021, THE FOURTH REVISION SURGERY WAS PERFORMED DUE TO THE IMPLANTS LOOSENING AT ACETABULAR SIDE. THE SURGEON COMMENTED THAT THERE IS NO LOOSENESS IN THE CONNECTION PART, BUT THERE MAY BE AN EFFECT OF TRUNIONOSIS IN THE CONNECTION PART BETWEEN THE NECK AND HEAD. IN THE REVISION, ZIMMER BIOMET AUGMENT, ZIMMER BIOMET CUP AND THE HEAD (J&J PRODUCT) WERE IMPLANTED. THE SUR

  Patient problems: Foreign Body Reaction

  MAUDE report 12106766 ↗
• InjuryMar 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2005, THE PRIMARY SURGERY WAS PERFORMED VIA THA WITH THE STEM, HEAD AND LINER IN QUESTION. ON (B)(6) 2021, THE PATIENT WAS URGENTLY TRANSPORTED TO THE HOSPITAL AND IT WAS FOUND THAT THE HEAD AND STEM DISASSOCIATED SECONDARY TO WEAR ON THE STEM. IN THE REVISION, THE SURGEON REMOVED THE HEAD, WASHED THE STEM, REPLACED THE LINER WITH THE NEW ONE AND IMPLANTED THE NEW HEAD. THE SURGEON COMMENTED THAT THE DISLOCATION IMPROVED, AND THE RANGE OF MOTION STABILIZED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2005. DOR: (B)(6) 2021; UNKNOWN HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11496713 ↗
• 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 11398072 ↗
• InjuryJul 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2007 VIA THA FOR THE PATIENT¿S RIGHT HIP JOINT. IT WAS REPORTED THAT THE PATIENT HAD UNCOMFORTABLE FEELING AT HER RIGHT HIP JOINT, AND THE SURGEON SUSPECTED THE DISLOCATION OF THE LINER (P/N: 121828048) BY X-RAY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE LINER, THE STEM (P/N: 900535210), THE HEAD (P/N: 152190057). DURING THE SURGERY, THE SURGEON FOUND THAT THE METALLOSIS OCCURRED DUE TO THE LINER¿S WEAR AND THE DISLOCATION, AND THERE WAS TISSUE LIKE PSEUDOTUMOR. THE REVISION SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. THE PATIENT IS UNDER OBSERVATION. THE SURGEON COMMENTED THAT THE BACKGROUND OF THE LINER¿S DISLOCATION WAS UNCLEAR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Dislocation; No Code Available

  MAUDE report 10290964 ↗
• InjuryJun 4, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SCREWS EXPLANTED WERE NON-DEPUY PRODUCTS AND THE IMPLANTS HAD A RING-SHAPED BLACKENED AS STATED IN THE EVENT.

  Patient problems: Foreign Body Reaction; No Code Available; Osteolysis; Pain

  MAUDE report 10119695 ↗
• InjuryMay 3, 2019Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: AD 24 JUNE 2019. THERE WAS A CORROSION BETWEEN THE HEAD NECK JUNCTION AND CORROSION BETWEEN THE STEM AND SLEEVE.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 8577937 ↗
• InjuryNov 5, 2018Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO PSEUDOTUMOR-LIKE IMAGES UNDER CT.

  Patient problems: Discomfort; Pain

  MAUDE report 8037454 ↗