Accolade 6058-0637DRecalls & reported problems
Howmedica Osteonics Corp. · 132 Degree Cemented Hip Stem · Class 2 · Implant
All models of Accolade (57)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327020762), received between Aug 23, 2023 and Aug 23, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Insert” (1 report).
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
- Difficult to Insert1
Patient problems
- Cardiac Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2023Difficult to Insert; Difficult to Insert
THE FOLLOWING OCCURRED DURING A PRIMARY LEFT HEMI HIP PROCEDURE: SURGEON TRIALED FOR AN ACCOLADE C STEM AND UNIPOLAR SLEEVE AND HEAD. AFTER TRIALING, THE SURGEON CEMENTED IN THE REAL STEM (COMPETITOR CEMENT). WHEN IMPACTING THE NEW SLEEVE AND HEAD, IT WOULD NOT LOCK TO THE STEM (SURGEON ATTEMPTED 6 TIMES). SURGEON THEN USED THE PREVIOUSLY USED TRIALS, WHICH WOULD NOT LOCK. A SECOND SLEEVE AND HEAD WERE USED AND WOULD NOT LOCK AFTER 3 ATTEMPTS. FINALLY, THE SURGEON FELT HE HAD THE SLEEVE AND HEAD 'WEDGED ONTO' THE STEM. ANESTHESIOLOGIST INDICATED THAT IT WAS TIME TO TURN THE PATIENT OVER AND THE PATIENT CODED (IT WAS NOTED THAT DUE TO THE PATIENT'S AGE AND HEALTH ISSUES, IT WAS DIFFICULT TO GET HER CLEARED FOR SURGERY IN THE FIRST PLACE). PATIENT WAS CLOSED WITH THE FINAL IMPLANTS IN SITU. THE REP LAST SAW THE PATIENT ALIVE AND HAS NOT BEEN NOTIFIED OF DEATH. OVERALL SURGICAL DELAY WAS 3 MINUTES.
Patient problems: Cardiac Arrest
MAUDE report 17608678 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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