NA 1018-36-511Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295001409), received between Oct 13, 2017 and Nov 18, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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.

• InjuryNov 18, 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 CHRONIC INFECTION OF RIGHT HIP. ON SUPPRESSIVE ABX. RIGHT HIP PAIN. XRAY SHOW SUBSIDENCE OF THE STEM. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23583674 ↗
• InjuryOct 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. EXPLANTED DURALOC. IMPLANTED PINNACLE. NO ADDITIONAL INFORMATION. DOI: UNKNOWN. DOR: (B)(6) 2021. (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 12673395 ↗
• InjuryMay 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON REVISED THIS A COUPLE OF MONTHS AGO, THE PATIENT WAS REVISED AGAIN BECAUSE OF HIP DISLOCATION. HE DECIDED TO REMOVE THE CUP LINER AND HEAD AND REPLACED WITH A STRYKER MDM CUP WITH OUR BALL TO HELP CORRECT THE PATIENTS DISLOCATION PROBLEMS. I DO NOT HAVE THE DATE OR PRODUCT NUMBER OF THE ORIGINAL CASE WHEN THE CUP WAS FIRST IMPLANTED. DOI: (B)(6) 2020 (HEAD AND LINER); DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10030733 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION OF POLY AND HEAD DUE TO INFECTION. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9506294 ↗
• InjuryFeb 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 8330823 ↗
• InjuryAug 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. THIS PATIENT HAS A RIGHT TOTAL HIP WITH AML STEM AND DURALOC CUP. THE HIP IS DISLOCATING, SO THE SURGEON DID A LINER AND HEAD EXCHANGE TO A CONSTRAINED CONSTRUCT. THE STEM AND CUP WERE WELL FIXED AND RETAINED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7798766 ↗
• InjuryJul 26, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATIONS. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7722466 ↗
• InjuryJul 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 7663486 ↗
• InjuryOct 13, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS OF ACETABULUM AND PERIPROSTHETIC DISLOCATION OF HIP JOINT. ALL ACETABULUM COMPONENTS WERE REMOVED AND ANOTHER COMPANY'S PRODUCTS WERE USED FOR THE REVISION.

  Patient problems: Joint Dislocation; Osteolysis

  MAUDE report 6948133 ↗