NA 1365-55-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10603295033998), received between Jan 10, 2017 and Jul 25, 2025 — classified as 54 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD MULTIPLE DISLOCATIONS SINCE PRIMARY SURGERY. REVISED WITH INCREASED HEAD LENGTH. DISLOCATED AGAIN AND DECISION WAS MADE TO USE A CONSTRAINED LINER. ALL COMPONENTS WERE WELL FIXED. EXCHANGED HEAD AND LINER. NON-COMPLIANT PATIENT. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22620820 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22054777 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. WASHED OUT AND CHANGED THE LINER AND HEAD BALL. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21207888 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 20736278 ↗
• InjuryOct 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD BEEN PREVIOUSLY REVISED DUE TO CHRONIC DISLOCATION. THE PATIENT CUP WAS WELL FIXED AND IN GOOD POSITION. THE SURGEON REMOVED THE HEAD AND LINER AND REPLACED THEM WITH A CONSTRAINED LINER AND NEW HEAD. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20522842 ↗
• InjurySep 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON REPLACED LINER AND HEAD DUE TO DISLOCATION. COMPONENTS APPEAR TO BE WELL POSITIONED BUT PATIENT HAS BACK ISSUES WHICH APPEARS TO CONTRIBUTE TO THE DISLOCATIONS. ALL DEPUY IMPLANTS REMOVED APPEAR TO BE IN GOOD WORKING CONDITION. THE SURGEON TRIALED A DUAL MOBILITY CONSTRUCT AND CONSIDERED AN ESC LINER BUT THOUGHT THE BEST OPTION WAS TO USE A LINER WITH A 40MM HEAD. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20136900 ↗
• InjurySep 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO ALLEGATION AGAINST THE STEM AND THE CUP.

  Patient problems: Joint Dislocation

  MAUDE report 20136778 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 19705650 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HIP REPLACEMENT FAILED AND PATIENT FELL AND THEN HAD EMERGENCY SURGERY FOR 6 HOURS. THEY HAD TO BREAK PATIENT'S FEMUR TO GET THE OLD ONE OUT. PATIENT'S FAMILY WERE NOT CALLING A LAWYER YET BECAUSE THEY WANT TO SPEAK TO SOMEONE REGARDING THIS. THIS HAPPENED ON (B)(6) 2024. HIP REPLACEMENT 2020 AND REVISION DUE TO LEG DISCREPANCY DUE WAS 2022. DOCTOR TOLD THAT IT WAS MADE BY DEPUY.

  Patient problems: Ambulation or Postural Difficulties; Fall; Physical Asymmetry

  MAUDE report 19153761 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON STATED THAT PATIENT WAS INFECTED AND ELECTED TO CHANGE ALL COMPONENTS. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. (B)(6). AFFECTED SIDE- RIGHT HIP

  Patient problems: Unspecified Infection

  MAUDE report 18338884 ↗
• InjurySep 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A 36+15.5 METAL ON ALTRX CONSTRUCT. PATIENT CONTINUED TO DISLOCATE AND WAS REVISED TO A PINNACLE REVISION CUP AND PINNACLE DUAL MOBILITY. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6)2016, DOR: (B)(6)2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17754505 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD MULTIPLE SURGERIES. ON (B)(6) 2021 HEMI ARTHROPLASTY WAS DONE AND STEM REMAINS FROM THIS PROCEDURE. ON (B)(6) 2021 HIP DISLOCATED AND CONVERTED TO CONSTRAINED TOTAL HIP BY SURGEON. ON (B)(6) 2021 CUP WAS REVISED AND DUAL MOBILITY WAS PLACED BY SURGEON. DER WAS FILED, CUP AND SCREW THAT LISTED ON THE DER, PLACED AT THIS TIME. ON (B)(6) 2022 IT WAS CONVERTED TO DM TO CONSTRAINED DUE TO DISLOCATION. DER WAS SUBMITTED, HEAD AND LINER PLACED AT THIS TIME. PATIENT PRESENTS IN ER WITH A PERIPROSTHETIC FACTURE OF RIGHT HIP WITH APPEARANCE OF POSSIBLE INFECTION SUPERIOR TO ACETABULAR COMPONENT. ALL COMPONENTS REMOVED AND PROSTALAC PLACED UNEVENTFULLY. THERE WAS LOOSENING OF FEMORAL COMPONENT POST FACTURE AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16859931 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HEAD AND LINER EXCHANGE DUE TO HIP INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 16466369 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNSTABLE COMPETITOR CUP-HEAD EXCHANGE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15527428 ↗
• InjuryNov 29, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION DUE TO METAL-ON-METAL WEAR, HIP FAILURE, PSEUDOTUMOR, AND SIGNIFICANTLY ELEVATED TOXIC BLOOD METAL IONS. THE OPERATIVE REPORT DOCUMENTS SEVERE DAMAGE TO THE TITANIUM TRUNION/STEM. A TITANIUM REVISION SLEEVE DESIGNED TO ADDRESS DAMAGE TO THE ORIGINAL TRUNION/STEM WAS NOT UTILIZED. AS A RESULT, THE NEWLY IMPLANTED COBALT/CHROMIUM ARTICUL/EZE HEAD (THIS WAS CAPTURED IN (B)(4)) WAS CONNECTED TO THE INDEX TITANIUM TRUNION/STEM AND CONTINUED TO GENERATE TOXIC METAL IONS FROM THE MIXED METAL MODULAR CONNECTION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Cellulitis; Depression; Discomfort; Embolism/Embolus; Fatigue; Foreign Body Reaction; Hematoma; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Nausea; Numbness; Pain; Physical Asymmetry; Swelling/ Edema; Unspecified Infection; Vomiting

  MAUDE report 12882515 ↗
• InjuryOct 14, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN, LOSS OF BALANCE, DIZZINESS, DIFFICULTY WALKING, STOMACH UPSET, DETERIORATION AND FAILURE OF THE PRODUCT, ELEVATED METAL IONS, ABRASION OF THE METAL ON METAL COMPONENTS WITH THE BEARING CAUSING METAL DEBRIS IN THE BODY, TISSUE DEHISCENCE, NECROSIS, HYPERTROPHIC SCARRING, ANTALGIA, LUMBAR STRAIN, FATIGUE, LIMITED ADL AND EMOTIONAL DISTRESS. DOI: (B)(6) 2011; DOR: (B)(6) 2020; UNKNOWN HIP.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Dizziness; Fatigue; Foreign Body Reaction; Loss of Range of Motion; Necrosis; Pain; Scar Tissue; Wound Dehiscence

  MAUDE report 12631208 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: THIS PC WAS CREATED TO ADDRESS CUP REVISION FOR INSTABILITY TO A CONSTRAINED LINER. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 12438066 ↗
• InjurySep 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS WAS THE FIRST AND ONLY REVISION SINCE THE PATIENT'S PRIMARY THA.

  Patient problems: Joint Dislocation

  MAUDE report 12406155 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT PATIENT EXPERIENCED INSTABILITY. LIP TO THE LINER WAS BROKEN OFF. DOI: (B)(6) 2015, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 12391210 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND HIP BECAME UNSTABLE. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020. DOI: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Laxity

  MAUDE report 12173436 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAIN. DOI: UNKNOWN. DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Pain

  MAUDE report 11713672 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION, IMPLANTS WERE EXPLANTED AND NEW IMPLANTS WERE PUT IN. DOI: UNKNOWN. DOR: (B)(6) 2021; UNKNOWN AFFECTED SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11446249 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2018. DOR: (B)(6) 2020. LEFT HIP.

  Patient problems: Pain

  MAUDE report 10983640 ↗
• InjuryNov 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CONSTRAINED LINER RING BROKEN. LINER AND HEAD REMOVED. NEW LINER/HEAD IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 10923019 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER REVISION WAS DUE TO INSTABILITY. DOI: (B)(6) 2020 DOR: (B)(6) 2020 RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10750212 ↗