NA 1018-13-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295001348), received between Jan 9, 2018 and Oct 25, 2023 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SAID PATIENT WOULD BENEFIT FROM A WASHOUT OF THEIR HIP AS THE HIP WAS SHOWING SIGNS OF INFECTION. CULTURES CAME BACK NEGATIVE, BUT THE SURGEON PROCEEDED TO WASHOUT THE HIP AND EXCHANGE THE FEMORAL HEAD. NEW HEAD WAS OPENED AND IMPLANTED, HIP WAS REDUCED AND CLOSING PROCESS BEGAN. NO ADVERSE EVENTS. DOI: UNKNOWN. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18004220 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 17861896 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15877470 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL HIP TO ADDRESS POLYETHYLENE LINER WEAR. DATE OF PRIMARY: (B)(6) 1983 (MANUFACTURER UNKNOWN). DATE OF REVISION #1: (B)(6) 1997. DATE OF REVISION #2: (B)(6) 2020. (RIGHT HIP). TREATMENT: FEMORAL HEAD AND ACETABULAR LINER REVISED.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Synovitis

  MAUDE report 12500584 ↗
• InjurySep 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  COMPASS CASE (B)(4) REPORT: REVISION WAS DONE FOR POLY WEAR, DISLOCATION. LOOSENING INTERFACE: NON-CEMENTED.

  Patient problems: Joint Dislocation

  MAUDE report 12440803 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 10749634 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. NO LOOSENING WAS NOTED. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10601852 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS CHIEF COMPLAINT WAS PAIN. THE SURGEON WENT IN AND FOUND THE POLY TO BE WORN. HE REPLACED THE HEAD AND POLY. KEEP IN MIND ALTHOUGH THE DATE ABOVE WAS GIVEN, THIS IS THOUGHT TO BE THE LAST TIME THIS PATIENT WAS REVISED. IT IS UNKNOWN. THE CUP AND STEM IS AN OLD GENERATION PRODUCT, SO IT COULD NOT HAVE BEEN HER PRIMARY SURGERY DATE. THE STEM AND CUP WERE WELL FIXED THIS IS WHY THE SURGEON CHOOSE A HEAD AND LINER REPLACEMENT WAS BEST. DOI: (B)(6) 2009. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8856999 ↗
• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POLY WEAR AND OSTEOLYSIS. A NEW POLY AND HEAD WERE IMPLANTED. DOI: (B)(6) 1997. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8588193 ↗
• InjurySep 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS A RIGHT TOTAL HIP WITH AML STEM AND DURALOC CUP. THE PATIENT HAD A CONSTRAINED LINER IMPLANTED IN APRIL AND HAS DISLOCATED. THE RING TO THE LINER WAS OVER THE NECK OF THE STEM. THE SURGEON DECIDED TO REMOVE THE CUP AND IMPLANT ANOTHER WITH BETTER VERSION. THE STEM WAS RETAINED AND IS WELL FIXED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7872419 ↗
• InjuryAug 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 1992; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 7794504 ↗
• InjuryMay 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT HAD IMPLANTED BIPOLAR EXPERIENCING PAINFUL HIP. PATIENT WAS CONVERTED INTO TOTAL HIP. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN SIDE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7493784 ↗
• InjuryApr 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT'S HIP REVISED DUE TO PAIN. A NEW DURALOC POLY 28X48 NEUTRAL WAS CEMENTED INTO THE ACETABULAR SHELL DUE TO SOME METAL WEAR ON THE INSIDE OF CUP. CUP WAS WELL FIXED THOUGH SURGEON FELT PRIOR CUP LOCKING MECHANISM MAY HAVE BEEN COMPROMISED DUE TO THE METAL WEAR ON THE INSIDE OF THE CUP. UNKNOWN HOW METAL WEAR OCCURRED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7391762 ↗
• InjuryFeb 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. LINER, RING AND HEAD WERE REPLACED. DOI: 1998 ; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7280018 ↗
• InjuryJan 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS METALLOSIS DUE TO BROKEN LOCKING RING, WORN AND LOOSE POLY LINER. DOI: (B)(6) 1998; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 7174979 ↗