NA 6250-65-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00889024119819), received between Sep 24, 2019 and May 15, 2026 — classified as 63 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• 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 25182864 ↗
• 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 24455857 ↗
• 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 24011901 ↗
• InjuryJan 8, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 6-MONTHS POST IMPLANTATION DUE TO DISLOCATION. DURING THE REVISION THE ACETABULAR COMPONENT WAS FOUND TO BE LOOSE. THE STEM WAS RETAINED AND ALL OTHER IMPLANTS WERE REVISED. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

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

  MAUDE report 24011821 ↗
• 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 23616759 ↗
• 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 23535036 ↗
• 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 23220215 ↗
• 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

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT IS BEING CONSIDERED FOR A HIP REVISION DUE TO LOOSENING WITH INFECTION UNLIKELY. PATIENT REPORTS PAIN, SWELLING, AND TROCHANTERIC BURSITIS DIAGNOSIS. REVISION IS PLANNED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 23027068 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: Bursitis; Pain

  MAUDE report 22893048 ↗
• InjuryAug 25, 2025Unintended Movement; Noise, Audible; Unintended Movement; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SNAPPING IN THE HIP APPROXIMATELY TWO YEARS POST-IMPLANTATION. IT WAS CONFIRMED THAT THE PATIENT HAD ILIOPSOAS TENDINITIS CAUSED BY IMPINGEMENT. PATIENT WAS REFERRED FOR AN INJECTION UNDER FLUOROSCOPY. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.

  Patient problems: Joint Impingement; Pain; Tendinopathy

  MAUDE report 22890395 ↗
• InjuryAug 25, 2025Adverse 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 REPORTED TENDERNESS OVER THE GREATER TROCHANTER CONSISTENT WITH BURSITIS APPROXIMATELY 1 YEAR LATER. THE PATIENT WAS USING CANES TO AMBULATE AND EXPERIENCED A MODERATE LIMP. THE SURGEON PROVIDED A CORTISONE INJECTION AND A TOPICAL ANTI-INFLAMMATORY CREAM, AND THE ISSUES WERE REPORTEDLY RESOLVED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Pain

  MAUDE report 22884455 ↗
• InjuryAug 18, 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

  IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO LOOSENING OF THE ACETABULAR TRIFLANGE COMPONENT AND ACETABULAR BONE FRACTURE DUE TO UNKNOWN REASON. PATIENT WAS EXPERIENCING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Bone Fracture(s); Pain

  MAUDE report 22826713 ↗
• InjuryJun 23, 2025Unstable; Unstable

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 22308511 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. AT 2 YEARS POSTOP, THE PATIENT REPORTS ONGOING MODERATE LOW BACK PAIN THAT WAS NOT PRESENT PRIOR TO THE INITIAL PROCEDURE. IT WAS INITIALLY THOUGHT TO BE GENERAL POSTOP SORENESS, BUT THE PAIN HAS NOT RESOLVED AND CONTINUES TO LIMIT DAILY ACTIVITIES. THE PATIENT HAS STARTED THERAPY FOR THE LOW BACK PAIN, TAKES NSAIDS FOR PAIN, AND USES A CANE FOR LONG DISTANCES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 22285206 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY EIGHT YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO PAIN AND DIFFICULTIES WITH ADLS. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 22157351 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS ANTICIPATING A REVISION DUE TO REPORTS OF WEAKNESS, IMBALANCE, WELLING, AND ACHING IN THE KNEE. PATIENT IS WEARING A LEFT KNEE BRACE FOR STABILITY AND COMFORT AND IS CONCERNED THAT AN ALTERED GAIT FROM THE KNEE WILL AFFECT HIP REPLACEMENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 22061777 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS ANTICIPATING A REVISION DUE TO REPORTS OF WEAKNESS, IMBALANCE, WELLING, AND ACHING IN THE KNEE. PATIENT IS WEARING A LEFT KNEE BRACE FOR STABILITY AND COMFORT AND IS CONCERNED THAT AN ALTERED GAIT FROM THE KNEE WILL AFFECT HIP REPLACEMENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 22061770 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON REASSESSMENT OF THE REPORTED EVENT AND ADDITIONAL INFORMATION RECEIVED, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE TENDONITIS WAS UNRELATED TO THE DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Tendinopathy

  MAUDE report 22025357 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON REASSESSMENT OF THE REPORTED EVENT AND ADDITIONAL INFORMATION RECEIVED, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE TENDONITIS WAS UNRELATED TO THE DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Tendinopathy

  MAUDE report 22025345 ↗
• InjuryApr 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN IN THE THIGH BONE MIDWAY DOWN THE FEMUR. THE DEVICES REMAIN IMPLANTED AND THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 21786542 ↗
• InjuryApr 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN IN THE THIGH BONE MIDWAY DOWN THE FEMUR. THE DEVICES REMAIN IMPLANTED AND THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 21786539 ↗
• 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 21784998 ↗
• InjuryApr 1, 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 21744525 ↗
• InjuryApr 1, 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 21744293 ↗
• InjuryFeb 25, 2025Loosening 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: Aseptic loosening; Failure of Implant

  MAUDE report 21459460 ↗