NA 1014-70-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295001270), received between Aug 22, 2017 and Aug 28, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Device Dislodged or Dislocated

  It was reported that the patient presented dislocated for a fall. Head and liner exchange was made and patient was stable with proper leg length.DOI: (b)(6) 2023.DOR: (b)(6) 2026.Affected side: Right.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 50505741 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD WAS EXCHANGED DUE TO INFECTION. DOI: (B)(6) 2009. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20855624 ↗
• InjuryNov 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 20605941 ↗
• InjuryJul 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REVISED DUE TO DISLOCATION. PREVIOUS CONSTRAINED LINER, SURGEON REPLACED IT. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 17421726 ↗
• InjuryJul 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A POLY AND HEAD EXCHANGE DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17351579 ↗
• MalfunctionFeb 23, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THE STERILE PACKAGING HAS SUSPECTED BREAK IN THE SEAL. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432232 ↗
• InjurySep 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO CHRONIC DISLOCATIONS. THE PATIENT TOLD TO SURGEON, THAT HER CURRENT DISLOCATED HIP WAS HER THIRD DISLOCATION. PATIENT'S DEPUY HIP HAD BEEN PREVIOUSLY REVISED ELSEWHERE. DURING THAT PROCEDURE, IT APPEARS THAT, PRIMARY DURALOC LINER WAS REPLACED BY A DURALOC CONSTRAINED LINER, BASED UPON THE PATIENT'S CURRENT COMPONENTS. DURING THIS PARTICULAR DISLOCATION. THE OUTER LOCKING RING OF THE CONSTRAINED LINER HAD BECOME SEPARATED FROM THE LINER AND THE FEMORAL HEAD HAD BECOME DISLOCATED FROM THE LINER. DURING THIS PARTICULAR REVISION PROCEDURE, THE DURALOC CUP, LINER AND LOCKING RING WERE REMOVED AND REPLACED BY A LARGER STRYKER ACETABULAR CUP. THE DEPUY 32MM LARGE TAPER METAL FEMORAL HEAD WAS REPLACED BY A DEPUY 36MM LARGE TAPER METAL FEMORAL HEAD. THE PATIENT'S AML DID NOT NEED TO BE REPLACED. THERE WAS NO LOOSENING. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15391653 ↗
• InjurySep 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT HIP WAS REVISED DUE TO CHRONIC DISLOCATIONS. THE PATIENT TOLD THE DOCTOR THAT HER CURRENT DISLOCATED HIP WAS HER THIRD DISLOCATION. HER DEPUY HIP HAD BEEN PREVIOUSLY REVISED ELSEWHERE. DURING THAT PROCEDURE, IT APPEARS THAT HER PRIMARY DURALOC LINER WAS REPLACED BY A DURALOC CONSTRAINED LINER, BASED UPON HER CURRENT COMPONENTS. DURING THIS PARTICULAR DISLOCATION. THE OUTER LOCKING RING OF THE CONSTRAINED LINER HAD BECOME SEPARATED FROM THE LINER AND THE FEMORAL HEAD HAD BECOME DISLOCATED FROM THE LINER. DURING THIS PARTICULAR REVISION PROCEDURE, THE DURALOC CUP, LINER AND LOCKING RING WERE REMOVED AND REPLACED BY A LARGER STRYKER ACETABULAR CUP. THE DEPUY 32MM LARGE TAPER METAL FEMORAL HEAD WAS REPLACED BY A DEPUY 36MM LARGE TAPER METAL FEMORAL HEAD. THE PATIENT'S AML DID NOT NEED TO BE REPLACED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15363041 ↗
• InjuryMar 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON REVISED A DURALOC CONSTRAINED LINER THAT HAD DISLOCATED. THE LINER AND HEAD WERE REMOVED AND NEW IMPLANTS USED. THERE WAS NO NOTED DEFICIENCY WITH THE EXPLANTED ITEMS. DOI: UNKNOWN. DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9904330 ↗
• InjuryMar 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9825572 ↗
• InjuryJun 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS INDICATED THAT THE PATIENT HIP WAS DISLOCATED SO THE SURGEON WANTED TO CHANGE THE CUP AND HEAD. DOI: (B)(6) 2010; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8746125 ↗
• InjuryJun 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  RIGHT HIP REVISION - ORIGINAL SURGERY DONE (B)(6) 2017. PATIENT HAD DISLOCATIONS, CONSTRAINED LINER LOCKING RING CAME OFF. REMOVED HEAD, LINER AND HOLE ELIMINATOR. LEFT ORIGINAL HEAD IN.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8686940 ↗
• InjuryJan 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD TOTAL HIP IN 1994. HE WAS REVISED TO A DURALOC CONSTRAINED LINER ON (B)(6) 2018. HE ACTUALLY DISLOCATED THIS AND WAS REVISED TO A TRI POLAR. HE HAD A COMPETITOR 44MM LINER CEMENTED INTO OUR DURALOC CUP AND THEN A DEPUY 44MM BIPOLAR WAS USED.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8264994 ↗
• InjuryDec 29, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED FOR ACUTE DISLOCATION. THE SAME IMPLANTS WERE REIMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 7154028 ↗
• InjuryAug 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PATIENT PRESENTED WITH GROIN PAIN. HER SOCKET HAD ALREADY BEEN REVISED ONCE BUT IT WAS 20 YEARS AGO. PARTS THAT WERE IN LOOKED LIKE A DEPUY HPS STEM AND A DURALOC REVISION SHELL 62 WITH A LIPPED 52 LINER. PARTS WERE HARD TO IDENTIFY. THE STEM WAS STILL WELL FIXED. CUP, LINER, AND SCREWS WERE REPLACED WITH MULTI HOLE GRIP, SCREWS, ALTRX LINER, AND LARGE TAPER 36 +11 HEAD.

  Patient problems: Pain

  MAUDE report 6811015 ↗