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Accolade 6021-0030Recalls & reported problems

Howmedica Osteonics Corp. · 127 Degree Neck Angle Hip Stem · Class 2 · Implant

All models of Accolade (57)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540510655), received between Feb 27, 2019 and Oct 13, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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

Device problems

  • Insufficient Device Problem Information2
  • Detachment of Device or Device Component1
  • Fracture1

Patient problems

  • Inflammation2
  • Injury2
  • Reaction2
  • Unspecified Infection2
  • Insufficient Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 13, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE TRUNNION BREAKING OFF THE STEM. INTRA-OPERATIVELY, IT WAS NOTED THE REMAINDER OF THE TRUNNION WAS STILL INSIDE THE FEMORAL HEAD, AND THAT THE REMAINDER OF THE STEM WAS GOUGING INTO THE LINER.

    Patient problems: Insufficient Information

    MAUDE report 15593056 ↗
  • InjuryFeb 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    THIS PI IS FOR REVISION 2 DONE (B)(6) 2017. IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE (B)(6) 2017 CUP AND LINER EXCHANGE "DID NOT RESOLVE THE PROBLEMS AND ON (B)(6) 2017 THE PATIENT WAS READMITTED BECAUSE OF A HIP INFILTRATION (PERIPROSTHETIC INFECTION-METALLOSIS), REQUIRING A BONE PUNCTURE. PATIENT DID NOT GET BETTER. ON (B)(6) 2017 HER SURGEONS REMOVED THE STRYKER STEM AND FEMORAL HEAD AND REPLACED ALL OF THE STRYKER COMPONENTS EXCEPT THE CUP AND LINER ALREADY REPLACED IN THE [PREVIOUS SURGERY]".

    Patient problems: Inflammation; Injury; Reaction; Unspecified Infection

    MAUDE report 8375714 ↗
  • InjuryFeb 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    THIS PI IS FOR PERIPROSTHETIC INFECTION- METALLOSIS AND BONE PUNCTURE DONE ON (B)(6) 2017. IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE (B)(6) 2017 CUP AND LINER EXCHANGE "DID NOT RESOLVE THE PROBLEMS AND ON (B)(6) 2017 THE PATIENT WAS READMITTED BECAUSE OF A HIP INFILTRATION (PERIPROSTHETIC INFECTION-METALLOSIS), REQUIRING A BONE PUNCTURE. PATIENT DID NOT GET BETTER. ON (B)(6) 2017 HER SURGEONS REMOVED THE STRYKER STEM AND FEMORAL HEAD AND REPLACED ALL OF THE STRYKER COMPONENTS EXCEPT THE CUP AND LINER ALREADY REPLACED IN THE [PREVIOUS SURGERY]".

    Patient problems: Inflammation; Injury; Reaction; Unspecified Infection

    MAUDE report 8375342 ↗

Other Prosthesis, hip, hemi-, femoral, metal devices

All Prosthesis, hip, hemi-, femoral, metal devices →

Sources and updates

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