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NA 1018-71-000Recalls & reported problems

Depuy (Ireland) · FEMORAL HEAD Diameter 28mm +11 14/16 TAPER · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295001416), received between Jun 8, 2018 and Aug 17, 2022 — classified as 6 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 18, 2026.

Most reported problems

Device problems

  • Device Dislodged or Dislocated3
  • Adverse Event Without Identified Device or Use Problem2
  • Insufficient Device Problem Information1

Patient problems

  • Joint Dislocation3
  • Pain3
  • No Code Available2
  • Not Applicable1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 1996. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

    Patient problems: Joint Dislocation

    MAUDE report 15243211 ↗
  • InjuryAug 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE EXACT DATES OF REVISIONS ARE NOT INDICATED IN THE CHART TODAY. THE PATIENT WAS EXPERIENCING RECURRENT DISLOCATIONS. AML STEM WITH A STRYKER CUP ARE CURRENTLY IMPLANTED. THE EXACT ORIGINAL IMPLANT DATE (1995 SOMETIME) AND PRODUCT NUMBER ARE UNKNOWN. HEAD AND LINER EXCHANGE PERFORMED. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

    Patient problems: Joint Dislocation

    MAUDE report 12362514 ↗
  • InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS REVISED TO ADDRESS PAIN. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT SIDE.

    Patient problems: No Code Available; Pain

    MAUDE report 10212555 ↗
  • InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION HIP DUE TO POLY WEAR WITH COMPETITORS CUP.

    Patient problems: No Code Available; Pain

    MAUDE report 7932118 ↗
  • InjurySep 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. THE PATIENT HAD AN 80MM ZIMMER CUP WITH A 28 +11 HEAD IN. THE POLY WAS EXCHANGED TO A 80X36 LINER AND A LARGE 36 X 11 INCHES TAPER WAS IMPLANTED. DOI: APPROXIMATELY IN THE 1990'S; DOR: (B)(4) 2018; RIGHT HI6.

    Patient problems: Joint Dislocation

    MAUDE report 7852678 ↗
  • InjuryJun 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    DER STATES THAT THE PATIENT HAD A POLY LINER AND FEMORAL HEAD REVISION TODAY FOR PAINFUL RIGHT HIP THAT WAS DONE 20 YEARS AGO. DOI: 1998; DOR: (B)(6) 2018; RIGHT HIP.

    Patient problems: Not Applicable; Pain

    MAUDE report 7582396 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources and updates

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