NA 6250-65-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00889024119857), received between Feb 1, 2022 and Sep 29, 2026 — classified as 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926932 ↗
• MalfunctionSep 24, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882156 ↗
• InjuryMay 15, 2026Migration

  No further information at the time of this report.

  Patient problems: Anemia; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inadequate Osseointegration; Joint effusion; Osteolysis; Pain; Unequal Limb Length

  MAUDE report 25182885 ↗
• MalfunctionMar 16, 2026Positioning Failure; Material Integrity Problem

  IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604086 ↗
• InjuryDec 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aseptic loosening

  MAUDE report 23811679 ↗
• InjuryDec 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aseptic loosening

  MAUDE report 23811600 ↗
• InjuryDec 15, 2025Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aseptic loosening

  MAUDE report 23811496 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THE PATIENT WAS EXPERIENCING WORSENING LEFT HIP, GROIN, BUTTOCK AND THIGH PAIN, LIMITED DAILY ACTIVITIES, AND MILD LIMP STARTING APPROXIMATELY 2 MONTHS POST-IMPLANTATION. THE PATIENT WAS ALSO NOTED TO HAVE SOME EDEMA TO THE FOOT. THE SURGEON PROVIDED A SHOE LIFT TO THE PATIENT FOR LEG LENGTH DISCREPANCY AND PATIENT CONTINUED PHYSICAL THERAPY; HOWEVER, THIS DID NOT PROVIDE ANY RELIEF. THE SURGEON REFERRED THE PATIENT TO AN ORTHOTIST FOR A CUSTOM SHOE. PATIENT ALSO PROVIDED FLECTOR PATCH FOR PAIN.

  Patient problems: Pain; Unequal Limb Length

  MAUDE report 22435147 ↗
• InjuryAug 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19906400 ↗
• InjuryMar 25, 2024Unstable; Unstable

  IT WAS REPORTED, THAT A PATIENT IS BEING SCHEDULED FOR A LEFT HIP REVISION. APPROXIMATELY, THREE MONTHS POST IMPLANTATION, DUE TO INADEQUATE FIXATION OF THE CUP AND PAIN. TO DATE, NO PROCEDURE HAS OCCURRED. ATTEMPTS HAVE BEEN MADE. AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18967471 ↗
• InjuryMar 25, 2024Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT IS BEING SCHEDULED FOR A LEFT HIP REVISION APPROXIMATELY THREE MONTHS POST IMPLANTATION DUE TO INADEQUATE FIXATION OF THE CUP AND PAIN. TO DATE, NO PROCEDURE HAS OCCURRED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18967467 ↗
• InjuryMar 21, 2024Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THREE DAYS AFTER A RIGHT HIP REVISION SURGERY, THE PATIENT REQUIRED A SECOND REVISION DUE TO A SCREW PULLING THROUGH THE ACETABULAR SHELL WITH SUBSEQUENT LOOSENING OF THE ACETABULAR SHELL. THE SURGEON REMOVED THE SHELL AND RE-IMPLANTED A NEW SHELL. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY, NO SURGICAL COMPLICATIONS, AND NO FOREIGN BODY WAS RETAINED. IT IS NOT KNOWN WHETHER THE PATIENT'S CONDITION OR ANATOMY CONTRIBUTED TO THE EVENT. NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18952578 ↗
• InjuryDec 1, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS BORN WITH HIP DYSPLASIA. THE PATIENT¿S CUP STARTED TO WEAR AND WAS REVISED. ONE YEAR POST IMPLANTATION, THE PATIENT FELL, AND THE CUP WAS FOUND TO BE LOOSE. THE SURGEON RECOMMENDED A CUSTOM IMPLANT.

  Patient problems: Fall

  MAUDE report 18245617 ↗
• InjuryOct 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN INITIAL REVISION OF UNKNOWN HIP PRODUCT FOR UNKNOWN REASONS WITH IMPLANTATION OF ZIMMER BIOMET PRODUCT AT THAT TIME. SUBSEQUENTLY, A SECOND REVISION WAS PERFORMED APPROXIMATELY A YEAR AND A HALF LATER DUE TO LOOSENING OF THE ACETABULAR IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 17885015 ↗
• InjuryJan 6, 2023Fracture; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY ONE-YEAR POST IMPLANTATION DUE TO LOOSENING AND AN INFECTION. DURING THE PROCEDURE IT WAS NOTED THAT SOME OF THE SCREWS WERE BROKEN, SOME OF THEM PULLED THROUGH THE CUP AND OTHERS HAD PULLED OUT OF THE CUP. THE CUP AND SCREWS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 16112725 ↗
• InjuryNov 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY 1-YEAR POST IMPLANTATION DUE TO SIGNIFICANT BONE LOSS RESULTING IN LOOSENING OF THE CUP. NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

  Patient problems: Erosion; Osteolysis

  MAUDE report 15877506 ↗
• MalfunctionOct 25, 2022Positioning Failure; Malposition of Device; Positioning Failure; Malposition of Device

  IT WAS REPORTED THAT THE SCREW WENT THROUGH THE CENTER HOLE OF THE CUP WHEN BEING IMPLANTED. THE SURGEON WAS UNABLE TO GET THE SCREW OUT SO IT WAS LEFT IMPLANTED. NO INTERVENTION OR HARM TO THE PATIENT IS REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666026 ↗
• InjurySep 16, 2022Migration; Migration

  IT WAS REPORTED THAT ONE OF THE SCREWS WENT THROUGH THE CUP. NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438955 ↗
• InjuryMay 3, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 6 MONTHS¿ POST IMPLANTATION DUE TO CUP NOT OBTAINING BIOLOGICAL FIXATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 14270461 ↗
• InjuryFeb 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP ARTHROPLASTY. THE PATIENT WAS NON-COMPLIANT (DUE TO THE PATIENT NOT FOLLOWING RESTRICTIONS AT REHAB) AND THE CUP, AUGMENT BLOCK, AND SCREWS LOOSENED. THEREFORE, THE PATIENT WAS REVISED WITH A BIGGER CUP, BIGGER AUGMENT, AND SCREWS APPROXIMATELY 1-2 MONTHS LATER. SUBSEQUENTLY, THE PATIENT WAS NON-COMPLIANT AGAIN, THEREFORE WILL BE REVISED AGAIN IN THE NEAR FUTURE WITH A CUSTOM TRIFFLANGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 13415840 ↗
• InjuryFeb 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP ARTHROPLASTY. THE PATIENT WAS NON-COMPLIANT (DUE TO THE PATIENT NOT FOLLOWING RESTRICTIONS AT REHAB) AND THE CUP, AUGMENT BLOCK, AND SCREWS LOOSENED. THEREFORE, THE PATIENT WAS REVISED WITH A BIGGER CUP, BIGGER AUGMENT, AND SCREWS APPROXIMATELY 1-2 MONTHS LATER. SUBSEQUENTLY, THE PATIENT WAS NON-COMPLIANT AGAIN, THEREFORE WILL BE REVISED AGAIN IN THE NEAR FUTURE WITH A CUSTOM TRIFFLANGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 13415838 ↗