NA 1521-90-051Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295276562), received between Sep 14, 2017 and Sep 25, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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.

• InjurySep 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY VIA THA AT ANOTHER HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, RECURRENT DISLOCATION OCCURRED. THE 22MM DIAMETER HEAD WAS USED IN THE INITIAL SURGERY, PROBABLY DUE TO THE SMALL SIZE OF THE CASE/PATIENT. A REVISION SURGERY IS SCHEDULED FOR (B)(6) 2024, AT HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 20302327 ↗
• InjuryOct 31, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2003, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA OF LEFT WITH AML-PLUS/DURALOCK IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT HAS FREQUENT DISLOCATIONS LAST 10 YEARS. A REVISION SURGERY IS PLANED SOON. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2003; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 15699171 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT THE SURGERY VIA THA FOR RIGHT HIP WITH IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT CONSULTED A DOCTOR ON (B)(6) 2022, ABOUT SYMPTOMS SUCH AS RIGHT HIP DISCOMFORT AND RIGHT KNEE COLLAPSE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. EXTRACTORS BY ZIMMER BIOMET WERE USED TO REMOVE THE CUP, RESULTING IN MINIMAL BONE LOSS. THE CUP WAS REPLACED TO G7 PRODUCED BY ZIMMER BIOMET, THE HOODED LINER INCREASED THE HEAD DIAMETER TO 36 MM, THE HEAD WAS EXTENDED TO +3 MM, AND THE STEM THAT WAS IMPLANTED ON (B)(6) 2011, HAS BEEN LEFT. NO DEFECT SUCH AS TRANIONOSIS WAS SEEN IN THE REMOVED IMPLANTS, AND THE POLY LINER WAS SLIGHTLY WORN ONLY. THE PATIENT HAS BEEN PARALYZED AS A SEQUELA OF INFANTILE PARALYSIS ON THE LEFT SIDE AND CONDUCTS ACTIVITIES OF DAILY LIVING WITH WEIGHT APPLIED ONLY TO THE RIGHT SIDE. THERE IS A CONSIDERABLE DIFFERENCE IN LEG LENGTH BETWEEN LEFT AND RIGHT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Fatigue; Physical Asymmetry

  MAUDE report 15649493 ↗
• InjuryFeb 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE THA SURGERY WITH THE STEM AND HEAD IMPLANT IN QUESTION. A DUAL MOBILITY PRODUCED BY ZIMMER BIOMET WAS USED FOR CUP. AFTER THE SURGERY, THE PATIENT HAD FREQUENT DISLOCATIONS ON AN UNKNOWN DATE. ON (B)(6) 2022, THE REVISION SURGERY WAS PERFORMED. STEM WAS REPLACED WITH NEW ONE (16×11×30+4NECK). THE SLEEVE WAS NOT REMOVED AND CONTINUED TO BE USED. HEAD IMPLANT WAS REPLACED WITH NEW SAME ONE. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13569557 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT THA WITH SROM-A. AFTER THE SURGERY, THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2021. THE REASON FOR REVISION SURGERY IS OSTEOLYSIS ON THE ACETABULAR. IN THE REVISION SURGERY, THE STEM AND HEAD ARE TO BE REPLACED WITH NEW ONES. DOI: (B)(6) 2006, DOR: (B)(6) 2021, UNKNOWN HIP.

  Patient problems: Osteolysis

  MAUDE report 12337364 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ABOUT 20YEARS BEFORE NOW, ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED VIA THA WITH THE LINER, HEAD AND WIRE IN QUESTION. ON AN UNKNOWN DATE, IT WAS CONFIRMED THAT THE WIRE, WHICH WAS USED AROUND THE FEMUR, HAD BEEN BROKEN, AND THE PUS WAS SPREADING, AND THE PATIENT FELT PAIN DUE TO THIS EVENT ON THE RIGHT SIDE. ON (B)(6) 2021, THE REVISION SURGERY WILL BE PERFORMED REPLACING THE LINER AND HEAD. ON (B)(6) 2021, THE REVISION SURGERY WAS PERFORMED. BEFORE ENTERING THE ROOM, THE PATIENT WAS ALREADY BLEEDING AT HER FEMORAL SHAFT PART, AND HER FEMUR WAS COVERED WITH GAUZE. AFTER THE SURGEON MADE AN INCISION, HE CUT THE CABLES AND REMOVED THEM WITH A PLIERS. AND HE REMOVED THE HEAD AND TRIED TO REMOVE THE LINER, BUT HE HAD DIFFICULTY IN REMOVING THE LINER WITH THE REMOVAL INSTRUMENTS. FINALLY, HE BROKE THE LINER WITH A CHISEL AND REMOVE THE LINER. HE IMPLANTED NEW HEAD AND LINER AND CLOSED THE INCISION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 11723824 ↗
• InjuryJan 8, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 1999 VIA THA FOR THE PATIENT'S LEFT HIP JOINT AT ANOTHER HOSPITAL ((B)(6) HOSPITAL). THE PATIENT'S POSTOPERATIVE PROGRESS WAS GOOD OVER THE LONG TERM. HOWEVER, FROM (B)(6) 2020, THE REPETITIVE DISLOCATION OCCURRED. AND WITH IT, THE PATIENT HAD A PAIN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 AT (B)(6) HOSPITAL DUE TO THE REPETITIVE DISLOCATION. IN THE REVISION SURGERY, THE SURGEON REMAINED THE STEM AND THE CUP, HE REPLACED THE LINER AND THE HEAD (ALSO REPLACED THE LOCKING RING ALONG WITH IT.) DURING THE SURGERY, THE SURGEON FOUND DISCOLORATION AND WEAR ON THE LINER. ABOUT THE HEAD, IT WAS FOUND THAT ACCORDING TO THE SALES RECORDS, THE IMPLANTED ONE WAS +3MM, BUT WHEN THE SALES REP CHECKED THE EXPLANTED ACTUAL ITEM, IT WAS ACTUALLY -3MM. BOTH OF INTEROPERATIVE TRAILING AND AFTER IMPLANTED STABILITY OF THE HIP JOINT WAS WELL. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT THE POSTOPERATIVE OPINION WAS GOOD FROM CHECKING BY X-RAY, AND THE PATIENT WILL BE UNDER FOLLOW-UP. BEFORE, THE DATES WERE UNKNOWN, THE PATIENT HAD THE PRIMARY SURGERY FOR THE RIGHT HIP JOINT VIA THA AND ALSO HAD THE PRIMARY SURGE

  Patient problems: Joint Dislocation; Pain

  MAUDE report 11140077 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2006 VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020. AS THE FIRST CHOICE, THE SURGEON PLANS TO REPLACE THE CUP (MANUFACTURED BY ANOTHER COMPANY) AT ACETABULAR SIDE, AND REPLACE THE S-ROM STEM AND THE HEAD AT FEMORAL SIDE. THE SURGEON PLANS TO PRESERVE THE SLEEVE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 10828881 ↗
• InjuryJul 14, 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. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2020 BY REMOVING THE STEM (P/N: 134522000) AND THE HEAD (P/N: 152190051) DUE TO ARMD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 10272825 ↗
• InjuryOct 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED VIA THA IN 2004 BY USING AML-P, DURALOC CUP 300 (DATE OF SURGERY WAS UNKNOWN). IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE LINER (P/N: UNKNOWN), THE HEAD (P/N: UNKNOWN) DUE TO DISLOCATION. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9260410 ↗
• InjuryApr 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2010. AFTER THE SURGERY, THE PATIENT COMPLAINED OF PAIN AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 DUE TO CENTRAL MIGRATION OF THE ENDURANCE HEAD. THE STEM AND THE SLEEVE WERE NOT REVISED. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Not Applicable; Pain

  MAUDE report 7399122 ↗
• InjurySep 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION POSSIBLY INDUCED BY ARMD. THE SURGEON COMMENTED THAT IF THE DISLOCATION WOULD HAPPEN AGAIN THEY WOULD PERFORM THE 2ND REVISION TO REPLACE THE STEM WITH A NEW IMPLANT.

  Patient problems: Foreign Body Reaction; Joint Dislocation

  MAUDE report 6866410 ↗