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NA 6250-65-20Recalls & reported problems

Zimmer, Inc. · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Zimmer hip prosthesis is a semi-constrained, uncemented metal-and-plastic hip implant used in total hip replacement. The 74 reports mostly describe the implant breaking, loosening within the bone, or shifting out of position, along with dislocation, pain, and infection that led to revision surgery. There were no deaths, 55 injuries, and 19 malfunctions. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
77
Deaths reported
0
Injuries reported
57
Recalls naming it
0

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00889024119802), received between Sep 3, 2021 and May 15, 2026 — classified as 57 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 2 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 1 reportsMay 2024: 2 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 4 reportsOct 2024: 2 reportsNov 2024: 7 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 3 reportsAug 2025: 2 reportsSep 2025: 2 reportsOct 2025: 0 reportsNov 2025: 6 reportsDec 2025: 2 reportsJan 2026: 1 reportsFeb 2026: 7 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 4 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem19
  • Fracture19
  • Loosening of Implant Not Related to Bone-Ingrowth17
  • Migration10
  • Malposition of Device5
  • Difficult to Insert4
  • Loss of or Failure to Bond4
  • Positioning Failure4

Patient problems

  • No Clinical Signs, Symptoms or Conditions22
  • Failure of Implant19
  • Pain18
  • Foreign Body In Patient6
  • Joint Dislocation6
  • Aseptic loosening5
  • Joint Laxity5
  • Unspecified Infection5

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

  • 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 25183756 ↗
  • InjuryMay 15, 2026Migration

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS UNDERGOING A SLOW PROGRESSIVE RECOVERY AND AFTER A SHORT WALK WITH WEIGHT BEARING, HAD AN ONSET OF PAIN. RADIOGRAPHIC IMAGING DISPLAYED A PERIPROSTHETIC FLUID COLLECTION, RESORPTION OF THE GRAFT, AND CUP PROTRUSION. PATIENT UNDERWENT AN ULTRASOUND GUIDED ASPIRATION. A WEEK LATER, PRESENTED TO THE EMERGENCY ROOM AND ADMITTED TO THE HOSPITAL WITH HIP PAIN, ANEMIA, AND HEMATOMA WITHIN THE ILIOPSOAS MUSCLE, AND REQUIRED BLOOD TRANSFUSIONS DURING THE HOSPITALIZATION. APPROXIMATELY 8 MONTHS POST-IMPLANTATION, UNDERWENT A REVISION WHERE A LARGE HEMATOMA WAS EVACUATED, THE CUP MIGRATED AND WAS FOUND WITHOUT SIGNS OF OSTEOINTEGRATION, AND ABSENCE OF THE ANTERIOR AND ACETABULAR FLOOR. DURING THE PROCEDURE, AN EXPECTED VENOUS BLEED FROM THE ACETABULAR FLOOR WAS ENCOUNTERED AND CORRECTED BY A VASCULAR SURGEON. DUE TO THE BLOOD LOSS, REQUIRED INTRA-OP AND POST-OPERATIVE BLOOD TRANSFUSIONS FOR HEMODYNAMIC STABILITY. ALL IMPLANTS, EXCEPT THE STEM WERE REVISED. FOLLOWING THE SURGERY, THE PATIENT REMAINED INTUBATED WITHIN ICU FOR A TOTAL OF THREE DAYS AND THEN UNDERWENT AN UNEVENTFUL POST-OPERATIVE RECOVERY AN

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

    MAUDE report 25182879 ↗
  • InjuryMay 15, 2026Migration

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS UNDERGOING A SLOW PROGRESSIVE RECOVERY AND AFTER A SHORT WALK WITH WEIGHT BEARING, HAD AN ONSET OF PAIN. RADIOGRAPHIC IMAGING DISPLAYED A PERIPROSTHETIC FLUID COLLECTION, RESORPTION OF THE GRAFT, AND CUP PROTRUSION. PATIENT UNDERWENT AN ULTRASOUND GUIDED ASPIRATION. A WEEK LATER, PRESENTED TO THE EMERGENCY ROOM AND ADMITTED TO THE HOSPITAL WITH HIP PAIN, ANEMIA, AND HEMATOMA WITHIN THE ILIOPSOAS MUSCLE, AND REQUIRED BLOOD TRANSFUSIONS DURING THE HOSPITALIZATION. APPROXIMATELY 8 MONTHS POST-IMPLANTATION, UNDERWENT A REVISION WHERE A LARGE HEMATOMA WAS EVACUATED, THE CUP MIGRATED AND WAS FOUND WITHOUT SIGNS OF OSTEOINTEGRATION, AND ABSENCE OF THE ANTERIOR AND ACETABULAR FLOOR. DURING THE PROCEDURE, AN EXPECTED VENOUS BLEED FROM THE ACETABULAR FLOOR WAS ENCOUNTERED AND CORRECTED BY A VASCULAR SURGEON. DUE TO THE BLOOD LOSS, REQUIRED INTRA-OP AND POST-OPERATIVE BLOOD TRANSFUSIONS FOR HEMODYNAMIC STABILITY. ALL IMPLANTS, EXCEPT THE STEM WERE REVISED. FOLLOWING THE SURGERY, THE PATIENT REMAINED INTUBATED WITHIN ICU FOR A TOTAL OF THREE DAYS AND THEN UNDERWENT AN UNEVENTFUL POST-OPERATIVE RECOVERY AN

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

    MAUDE report 25182866 ↗
  • MalfunctionMay 14, 2026Fracture

    No further information at the time of this report.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25174788 ↗
  • InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING A FOLLOW-UP VISIT TWO WEEKS POST-IMPLANTATION, THE PATIENT PRESENTED WITH SLOW WOULD HEALING AND WAS PRESCRIBED AN ANTIBIOTIC. AT THE NEXT FOLLOW-UP, THE ISSUE WAS RESOLVED, AND ALL COMPONENTS REMAIN IMPLANTED WITHOUT COMPLICATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Patient problems: Impaired Healing

    MAUDE report 24582487 ↗
  • 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 24455877 ↗
  • 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 24455875 ↗
  • 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 24455861 ↗
  • 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 24455848 ↗
  • MalfunctionFeb 22, 2026Positioning Failure; Device-Device Incompatibility

    IT WAS REPORTED THAT DURING SURGERY, THE SURGEON HAD DIFFICULTY DRIVING THE SCREW INTO THE ACETABULAR CUP HOLE. SWITCHING TO AUTOMATED, BATTERY POWERED IMPACTION TO STRIKE THE SCREWDRIVER CAUSED THE SCREW TO GO PAST THE CUP¿S SCREW HOLE. THERE ARE NO PLANS TO REMOVE THE SCREWS 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 24410571 ↗
  • InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY FOLLOWED BY A REVISION FIVE MONTHS POST-OPERATIVE DUE TO THREE RECURRENT DISLOCATIONS. A SECOND REVISION WAS PERFORMED APPROXIMATELY 9 YEARS DUE TO PAIN AND OSSIFICATION. TWO MONTHS POST-SECOND REVISION, PATIENT UNDERWENT A DAIR FOR WOUND DEHISCENCE A THIRD REVISION DUE TO RECURRENT DISLOCATIONS. FOLLOWING THE REVISION, EXPERIENCED EXCRUCIATING PAIN DUE A FRACTURED ACETABULAR SCREW AND UNDERWENT A FOURTH REVISION. DURING THE PROCEDURE, THE PATIENT REPORTS, THE CONSTRUCT FELL PART IN THE SURGEONS AND THE GLUTEUS MUSCLES WERE DAMAGE. SUBSEQUENTLY, FOLLOWING THE PROCEDURE, THE RIGHT QUAD MUSCLE IS NOT FIRING, LEADING TO AN INABILITY TO WALK. THE PATIENT IS ALLEGING THAT DURING THE FOURTH REVISION, A NERVE WAS FLATTENED FROM EITHER THE FRACTURED SCREW OR THE PROCEDURE. NERVE CONDUCTION STUDIES HAVE BEEN PERFORMED AND IDENTIFIED FEMORAL NEUROPATHY. ALL IMPLANTS REMAIN IMPLANTED AT THIS TIME AND THEN PATIENT IS PLANNING TO BE ADMITTED TO AN INPATIENT REHABILITATION CENTER FOR AN INTENSE REHAB PROGRAM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

    MAUDE report 24316127 ↗
  • MalfunctionFeb 4, 2026Positioning Failure

    IT WAS REPORTED THAT THE SURGEON CHOSE TO REMOVE THE SCREW FROM THE METAL ACETABULAR IMPLANT BECAUSE HE THOUGHT IT DID NOT GIVE THE FINAL PROPER TIGHTENING, HINDERING THE FIXATION OF THE POLYETHYLENE IN THE METAL IMPLANT. SURGEON CHOSE TO LEAVE ONLY ONE SCREW IN ANOTHER HOLE OF THE ACETABULUM. NO PATIENT HARM OR IMPACT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24259095 ↗
  • InjuryJan 8, 2026Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Patient problems: Aseptic loosening; Damage to Ligament(s); Joint Dislocation

    MAUDE report 24011772 ↗
  • InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Patient problems: Joint Dislocation; Metal Related Pathology; Periprosthetic fracture

    MAUDE report 23879064 ↗
  • InjuryDec 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT THE ELDERLY PATIENT WAS REVISED APPROXIMATELY 1 (ONE) YEAR AFTER INITIAL IMPLANTATION BECAUSE SHE FELL ON HER HIP AND ONE OF THE SCREWS BROKE. THE SURGEON THOUGHT THAT IT HAPPENED BEFORE THE CUP HAD GOT ADEQUATE FIXATION AND BECAUSE OF HER AGE, DISLODGED. THE SURGEON BELIEVES HER AGE AND FRAGILITY WAS THE CAUSE OF HER FALL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Patient problems: Aseptic loosening

    MAUDE report 23811751 ↗
  • 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 23616769 ↗
  • InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Insufficient Information

    MAUDE report 23595892 ↗
  • InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY FOLLOWED BY A REVISION FIVE MONTHS POST-OPERATIVE DUE TO THREE RECURRENT DISLOCATIONS. A SECOND REVISION WAS PERFORMED APPROXIMATELY 9 YEARS DUE TO PAIN AND OSSIFICATION. TWO MONTHS POST-SECOND REVISION, PATIENT UNDERWENT A DAIR FOR WOUND DEHISCENCE A THIRD REVISION DUE TO RECURRENT DISLOCATIONS. FOLLOWING THE REVISION, EXPERIENCED EXCRUCIATING PAIN DUE A FRACTURED ACETABULAR SCREW AND UNDERWENT A FOURTH REVISION. DURING THE PROCEDURE, THE PATIENT REPORTS, THE CONSTRUCT FELL PART IN THE SURGEONS AND THE GLUTEUS MUSCLES WERE DAMAGE. SUBSEQUENTLY, FOLLOWING THE PROCEDURE, THE RIGHT QUAD MUSCLE IS NOT FIRING, LEADING TO AN INABILITY TO WALK. THE PATIENT IS ALLEGING THAT DURING THE FOURTH REVISION, A NERVE WAS FLATTENED FROM EITHER THE FRACTURED SCREW OR THE PROCEDURE. NERVE CONDUCTION STUDIES HAVE BEEN PERFORMED AND IDENTIFIED FEMORAL NEUROPATHY. ALL IMPLANTS REMAIN IMPLANTED AT THIS TIME AND THEN PATIENT IS PLANNING TO BE ADMITTED TO AN INPATIENT REHABILITATION CENTER FOR AN INTENSE REHAB PROGRAM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

    MAUDE report 23543836 ↗
  • InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

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

    MAUDE report 23543828 ↗
  • InjuryNov 12, 2025Migration; Migration

    IT WAS REPORTED THAT POSTOPERATIVE FINDINGS REVEALED THAT THE ACETABULAR SCREW HAD PASSED THROUGH THE SCREW HOLE OF THE ACETABULAR CUP. NO PLAN TO REMOVE THE SCREW. TWO PRODUCT LABELS WERE SUBMITTED; HOWEVER, THE SURGEON CANNOT CONFIRM WHICH SCREW IS THE COMPLAINT.

    Patient problems: Foreign Body In Patient

    MAUDE report 23535049 ↗
  • InjuryNov 10, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT APPROXIMATELY TWELVE DAYS POST-IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO INSTABILITY AND ACETABULAR FAILURE. THE PATIENT EXPERIENCED PAIN DUE TO A FRACTURED SCREW. THE GLUTEUS MUSCLES HAD BEEN DAMAGED. THE SHELL AND SCREWS WERE REVISED. PATIENT REPORTS THE CONSTRUCT FELL APART DURING THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Joint Laxity; Muscle/Tendon Damage; Pain

    MAUDE report 23513910 ↗
  • InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

    Patient problems: Aseptic loosening; Bacterial Infection; Bursitis; Medical device site infection; Pain; Septic loosening; Swelling/ Edema

    MAUDE report 23027067 ↗
  • InjurySep 8, 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 HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A SECOND REVISION ON AN UNKNOWN DATE DUE TO INSUFFICIENT FIXATION OF THE CUP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Aseptic loosening

    MAUDE report 22991038 ↗
  • 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 22882952 ↗
  • InjuryAug 11, 2025Fracture; Fracture

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

    Patient problems: Foreign Body In Patient

    MAUDE report 22778908 ↗

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

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Sources and updates

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