NA 1018-75-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295001423), received between Oct 26, 2017 and May 8, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2025Degraded; Degraded

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INFECTION AND PAIN. AT REMOVAL THERE WAS CORROSION ON THE HEAD.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21983933 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ABOUT 15 YEARS AGO THE PATIENT UNDERWENT A REVISION FOR UNKNOWN REASONS. A COMPETITOR LINER WAS CEMENTED INTO THE CUP AND A COMPETITOR BIPOLAR HEAD WAS PLACED. (B)(6) 2024: REVISION DUE TO DISASSOCIATION OF THE COMPETITOR BIPOLAR HEAD. INFECTION WAS QUESTIONED, BUT CULTURES WERE NEGATIVE. SAME SIZE BIPOLAR HEAD WAS PLACED, BUT DEPUY SYNTHES AT THIS TIME. (B)(6) 2024 ((B)(4)): REVISION DUE TO DISLOCATION OF THE DEPUY BIPOLAR HEAD WITH COMPETITOR LINER. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19509964 ↗
• InjuryOct 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION DUE TO DISLOCATION. DOI: UNKNOWN, DOR: (B)(6) 2021 AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12569790 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF ACETABULAR LINER AND FEMORAL HEAD DUE TO PAIN. REVISED TO A 36MM X 54 +4/10 DEGREE DURALOC POLY AND LARGE TAPER 36MM +11 HEADBALL. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Pain

  MAUDE report 11841709 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND POLY WEAR. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9369597 ↗
• InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATES THAT THE PATIENT HAD A REVISION OF THE RIGHT ACETABULAR WITH A COMPETITOR CUP AND LINER. THE HEAD WAS REPLACED WITH A 28MM + 15 COCR HEAD IN A 40MM/28MM BIPOLAR. THERE WAS A PREVIOUS MDR DONE AT THE TIME OF REVISION. TODAY THIS PATIENT WOUND IS RED AND DRAINING. SURGEON DECIDED TO CHANGE TO A COMPETITOR CONSTRAINED LINER AND A 36MM+11 14/16 HEAD. THE WOUND WAS DEBRIDED AND IRRIGATED WELL AND CLOSED. INFECTION IS PRESENT IN THIS WOUND. NO OTHER INFORMATION IS AVAILABLE.  DOI: (B)(6) 2018; DOR; (B)(6) 2018; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7650736 ↗
• InjuryMar 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS REPEATED DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2018 RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7324301 ↗
• InjuryFeb 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION AND WAS CONVERTED TO A CONSTRAINED LINER. DISLOCATION WAS DUE TO NOT FOLLOWING POST-OP INSTRUCTIONS. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7258736 ↗
• InjuryOct 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LIMP ON WALKING.

  Patient problems: Pain

  MAUDE report 6981416 ↗