NA 6250-65-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00889024119796), received between Dec 8, 2021 and Jul 31, 2026 — classified as 16 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Fracture

  It was reported that the screw broke during insertion.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098360 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-HIP PROCEDURE, THE PATIENT PRESENTED WITH SEPTIC SHOCK DUE TO MRSA INFECTION IN THE HIP. THEY HAD FEVERS, DIFFICULTY WALKING, SWELLING, ABSCESS, AND POSITIVE CULTURES FOR MRSA AND SEPTIC SHOCK. THE HEAD WAS EXCHANGED IN AN I&D PROCEDURE BEFORE THE STAGE ONE REVISION ONE MONTH LATER. OP RECORDS NOTE PURULENT FLUID, LARGE FASCIAL DEHISCENCE. ALL COMPONENTS WERE REPLACED WITH A CEMENT SPACER DURING STAGE ONE WITHOUT COMPLICATIONS. THE STAGE TWO REVISION TOOK PLACE FOUR MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Abscess; Ambulation or Postural Difficulties; Bacterial Infection; Medical device site infection; Purulent Discharge; Scar Tissue; Sepsis; Septic Shock; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25183761 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-HIP PROCEDURE, THE PATIENT PRESENTED WITH SEPTIC SHOCK DUE TO MRSA INFECTION IN THE HIP. THEY HAD FEVERS, DIFFICULTY WALKING, SWELLING, ABSCESS, AND POSITIVE CULTURES FOR MRSA AND SEPTIC SHOCK. THE HEAD WAS EXCHANGED IN AN I&D PROCEDURE BEFORE THE STAGE ONE REVISION ONE MONTH LATER. OP RECORDS NOTE PURULENT FLUID, LARGE FASCIAL DEHISCENCE. ALL COMPONENTS WERE REPLACED WITH A CEMENT SPACER DURING STAGE ONE WITHOUT COMPLICATIONS. THE STAGE TWO REVISION TOOK PLACE FOUR MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Abscess; Ambulation or Postural Difficulties; Bacterial Infection; Medical device site infection; Purulent Discharge; Scar Tissue; Sepsis; Septic Shock; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25183723 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-HIP PROCEDURE, THE PATIENT PRESENTED WITH SEPTIC SHOCK DUE TO MRSA INFECTION IN THE HIP. THEY HAD FEVERS, DIFFICULTY WALKING, SWELLING, ABSCESS, AND POSITIVE CULTURES FOR MRSA AND SEPTIC SHOCK. THE HEAD WAS EXCHANGED IN AN I&D PROCEDURE BEFORE THE STAGE ONE REVISION ONE MONTH LATER. OP RECORDS NOTE PURULENT FLUID, LARGE FASCIAL DEHISCENCE. ALL COMPONENTS WERE REPLACED WITH A CEMENT SPACER DURING STAGE ONE WITHOUT COMPLICATIONS. THE STAGE TWO REVISION TOOK PLACE FOUR MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Abscess; Ambulation or Postural Difficulties; Bacterial Infection; Medical device site infection; Purulent Discharge; Scar Tissue; Sepsis; Septic Shock; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25183716 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-HIP PROCEDURE, THE PATIENT PRESENTED WITH SEPTIC SHOCK DUE TO MRSA INFECTION IN THE HIP. THEY HAD FEVERS, DIFFICULTY WALKING, SWELLING, ABSCESS, AND POSITIVE CULTURES FOR MRSA AND SEPTIC SHOCK. THE HEAD WAS EXCHANGED IN AN I&D PROCEDURE BEFORE THE STAGE ONE REVISION ONE MONTH LATER. OP RECORDS NOTE PURULENT FLUID, LARGE FASCIAL DEHISCENCE. ALL COMPONENTS WERE REPLACED WITH A CEMENT SPACER DURING STAGE ONE WITHOUT COMPLICATIONS. THE STAGE TWO REVISION TOOK PLACE FOUR MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Abscess; Ambulation or Postural Difficulties; Bacterial Infection; Medical device site infection; Purulent Discharge; Scar Tissue; Sepsis; Septic Shock; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25183712 ↗
• InjuryApr 20, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO PAIN, AMBULATION DIFFICULTIES, AND ACETABULAR FIXATION FAILURE. THE PATIENT REPORTED SEVERE PAIN AND THEY WERE UNABLE TO WALK. THE STEM WAS RETAINED AND ALL OTHER COMPONENTS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Pain

  MAUDE report 24926212 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INSTABILITY, RECURRENT DISLOCATIONS, AND IMPINGEMENT FROM POOR POSITIONING OF IMPLANTS. THE SURGEON ATTRIBUTED THE RECURRENT DISLOCATION TO POOR CUP PLACEMENT. THE TROCHANTERIC CLAW HAD ANTERIOR FIXATION RESULTING IN TISSUE IMPINGEMENT. DURING THE REVISION, A COMPETITOR CUP WAS CEMENTED INTO THE EXISTING CUP; THE HEAD AND LINER WERE EXCHANGED; AND THE STEM AND CLAW WERE RETAINED WITH SOME TISSUE AROUND THE GREATER TROCHANTER DEBRIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Joint Impingement; Joint Laxity; Pain

  MAUDE report 24455856 ↗
• MalfunctionDec 4, 2025Fracture; Fracture

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717399 ↗
• InjuryNov 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING. THE CUP AND SCREWS WERE EXPLANTED.

  Patient problems: Aseptic loosening

  MAUDE report 23616776 ↗
• InjuryOct 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Nerve Damage; Neuropathy

  MAUDE report 23220220 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE AND A HALF YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INFECTION, PAIN, INFLAMMATION, AND HEAD AND TRUNNION DISASSOCIATION DEMONSTRATED ON X-RAYS. DURING THE REVISION THE HEAD WAS CONFIRMED FRACTURED, THERE WAS SIGNIFICANT SCAR TISSUE, AND NECROTIC TISSUE WAS DEBRIDED FROM THE CUP. ALL COMPONENTS REVISED AND A CEMENT SPACER IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Medical device site infection; Necrosis; Pain; Scar Tissue

  MAUDE report 22882967 ↗
• MalfunctionMar 10, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED WHEN OPENING THE HIP SCREW, THE INNER PACKAGING WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH A NEW SCREW. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558603 ↗
• InjuryApr 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 14 MONTHS POST IMPLANTATION DUE TO A LOOSE ACETABULAR COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19041918 ↗
• InjuryDec 12, 2023Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  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: Failure of Implant; Insufficient Information

  MAUDE report 18312402 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY 1 YEAR LATER DUE TO BONE LOSS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 17471383 ↗
• InjuryNov 8, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP PROCEDURE. DURING THE PROCEDURE, WHILE SECURING THE SHELL, A SCREW SLIPPED ENTIRELY THROUGH THE SCREW HOLE. THERE WAS A DELAY OF FIFTEEN MINUTES WHILE THE SURGEON ATTEMPTED TO REMOVE THE SCREW, BUT WAS UNABLE. THE SCREW REMAINS IN THE PATIENT. DUE DILIGENCE IS IN PROCESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15754549 ↗
• MalfunctionOct 10, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE SURGEON PERFORMED THE PROCEDURE AS USUAL, DRILL, DEPTH GAUGE, AND SCREW INSERTION, BUT THE SCREW DID NOT GO IN, SO HE PERFORMED THE SAME OPERATION SEVERAL TIMES AND THE SCREW PASSED THROUGH THE HOLE IN THE CUP. IT COULD NOT BE REMOVED AND REMAINED IN PLACE. NO ADVERSE CONSEQUENCES WERE 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 15572023 ↗
• InjuryDec 8, 2021Migration; Migration

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 12960912 ↗
• InjuryDec 8, 2021Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED 2 YEARS POST IMPLANTATION FOR ASEPTIC LOOSENING. CONTINUUM CUP EXPLANTED AND REPLACED WITH A CUP FROM ANOTHER COMPANY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 12960859 ↗
• InjuryDec 8, 2021Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED 2 YEARS POST IMPLANTATION FOR ASEPTIC LOOSENING. CONTINUUM CUP EXPLANTED AND REPLACED WITH A CUP FROM ANOTHER COMPANY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 12960856 ↗