NA 6250-65-30Recalls & reported problems
Zimmer, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer hip prosthesis has 91 adverse event reports since September 2019, with no deaths and 67 injuries. Reports mostly describe fractured parts during surgery, loosening, and migration, sometimes requiring revision and causing pain. No recalls name this device. Reports fell from 20 to 8 in the last 12 months.
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
- 91
- Deaths reported
- 0
- Injuries reported
- 67
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00889024119826), received between Sep 24, 2019 and May 27, 2026 — classified as 67 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Fracture” (22 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem29
- Fracture22
- Loosening of Implant Not Related to Bone-Ingrowth17
- Migration10
- Positioning Failure9
- Difficult to Insert5
- Malposition of Device2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Pain23
- Failure of Implant19
- Foreign Body In Patient9
- Ambulation or Postural Difficulties8
- Insufficient Information7
- Unspecified Infection7
- Unequal Limb Length6
Recent adverse event reports
The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Fracture
IT WAS REPORTED THAT THE SCREW BROKE DURING SURGERY. 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 25310870 ↗MalfunctionMar 25, 2026Scratched Material
IT WAS REPORTED THAT THE SCREW HEAD WAS SCRATCHED DURING INSERTION. THE SCREW WAS NOT USED, TOOK ABOUT 3 MINUTES TO REPLACE PRODUCT. NO PATIENT HARM OR IMPACT REPORTED. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687012 ↗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 24316126 ↗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 23811559 ↗InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION.
Patient problems: Loss of Range of Motion; Pain; Unequal Limb Length
MAUDE report 23569555 ↗InjuryNov 13, 2025Migration; Migration
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: Ambulation or Postural Difficulties; Deformity/ Disfigurement; Fever; Hypersensitivity/Allergic reaction; Itching Sensation; Loss of Range of Motion; Nerve Damage; Neuropathy; Pain; Skin Discoloration; Swelling/ Edema; Unequal Limb Length
MAUDE report 23542026 ↗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 23513903 ↗InjurySep 16, 2025Fracture; Fracture
MalfunctionSep 8, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE INSERTING THE SCREWS INTO THE CUP, ONE OF THE SCREWS FRACTURED AND THE OTHER SCREW WENT THROUGH THE HOLE OF THE CUP. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THE SURGEON NOTED THAT THE PATIENT HAD HARD BONE. 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 22991188 ↗MalfunctionSep 8, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT WHILE INSERTING THE SCREWS INTO THE CUP, ONE OF THE SCREWS FRACTURED AND THE OTHER SCREW WENT THROUGH THE HOLE OF THE CUP. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THE SURGEON NOTED THAT THE PATIENT HAD HARD BONE. 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 22991183 ↗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 22991040 ↗InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REQUIRED A CORTISONE INJECTION FOR TROCHANTERIC BURSITIS APPROXIMATELY FOUR YEARS AFTER IMPLANTATION. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: Bursitis
MAUDE report 22798126 ↗InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 1 YEAR AND 3 MONTHS POST IMPLANTATION DUE TO PAIN, MILD LIMP DUE TO LEG LENGTH DISCREPANCY, STIFFNESS, POPPING AND GRINDING NOISE THE PATIENT WAS EXPERIENCING WHEN WALKING MAKING MOVING DIFFICULT. DURING THE REVISION, THICK CAPSULE WITH POSTERIOR IMPINGEMENT OF THE TROCHANTER ON THE PELVIS WAS NOTED AS WELL AS A SLIGHTLY RETROVERTED ACETABULAR CUP. TRUNNION FOUND TO BE CLEAN WITHOUT SIGNIFICANT DAMAGE. THE ACETABULAR CUP, FEMORAL HEAD AND POLYETHYLENE LINER WERE REMOVED AND REPLACED. THE SURGEON WAS ABLE TO RESTORE LEG LENGTH. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Joint Impingement; Pain; Unequal Limb Length
MAUDE report 22553472 ↗InjuryJul 17, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 22536102 ↗MalfunctionJul 9, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22460661 ↗InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PREVIOUS HIP REVISION WHERE ZB PRODUCT WAS IMPLANTED. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN APPROXIMATELY 9 MONTHS POST IMPLANTATION. THE DEVICES REMAIN IMPLANTED, AND PATIENT HAS BEEN REFERRED FOR NON-SURGICAL TREATMENT OPTIONS. NO INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain; Unequal Limb Length
MAUDE report 22436122 ↗InjuryJun 13, 2025Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO SHIFTING OF THE CUP INTO A SLIGHTLY DIFFERENT POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 22203213 ↗InjuryJun 13, 2025Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY ONE YEAR'S POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO SHIFTING OF THE CUP INTO A SLIGHTLY DIFFERENT POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 22203212 ↗MalfunctionMay 19, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SCREW COULD NOT BE ASSEMBLED WITH THE CUP. SURGEON FOLLOWED TECHNIQUE TO INSERT CUP AND USED THE CORRESPONDING SPECIFIED DRILL BIT. AFTER MEASURING LENGTH AND SELECTING SCREW, THE SCREW COULD NOT BE COMPLETELY SCREWED INTO THE CUP AND APPEARED TO BE SLIGHTLY SLIPPERY. ANOTHER SCREW WAS ABLE TO BE USED. THERE WAS A FIVE MINUTE DELAY. 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 22043411 ↗InjuryMay 12, 2025Positioning Failure; Positioning Failure
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Atrophy; Burning Sensation; Fatigue; Hypersensitivity/Allergic reaction; Itching Sensation; Malaise; Pain; Swelling/ Edema
MAUDE report 22003434 ↗MalfunctionMay 9, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE TRILOGY SCREW WENT THROUGH THE G7 50MM CUP. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21992612 ↗InjuryApr 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, A PATIENT FROM A STUDY REPORTED MODERATE PAIN AND WAS DIAGNOSED WITH TROCHANTERIC BURSITIS AND GIVEN A CORTISONE INJECTION. ALL IMPLANTS REMAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bursitis; Pain
MAUDE report 21784997 ↗MalfunctionMar 24, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW BROKE. ALL PIECES WERE RETRIEVED. THERE WAS NO KNOWN PATIENT IMPACT OR CONSEQUENCES. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21676535 ↗InjuryFeb 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY FIVE YEARS POST IMPLANTATION DUE TO LOOSENING OF THE CUP. THE CUP WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 21321873 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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