Accolade 6058-0335DRecalls & reported problems
Howmedica Osteonics Corp. · 132 Degree Cemented Hip Stem · Class 2 · Implant
All models of Accolade (57)
Data updated Oct 16, 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 07613327020748), received between Aug 24, 2020 and Aug 24, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of Osseointegration” (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 16, 2026.
Most reported problems
Device problems
- Loss of Osseointegration1
Patient problems
- Fall1
- Inadequate Osseointegration1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2020Loss of Osseointegration; Loss of Osseointegration
DOCTOR REPORTS PATIENT AT STATUS POST LEFT ANTERIOR HIP REPLACEMENT DONE APPROXIMATELY 2 WEEKS AGO MAY HAVE FALLEN AND NOW HAS AN ACETABULAR FRACTURE AND THE CUP HAS SHIFTED AS WELL AS PROTRUDED THROUGH THE MEDIAL WALL. DOCTOR REQUESTED TO REVISE THE ACETABULUM. THE CUP WAS CAREFULLY REMOVED AND THEN PREPARATION OF THE ACETABULUM WAS PERFORMED TO IMPLANT A TRITANIUM REVISION CUP. AFTER BONE GRAFTING THE MEDIAL WALL THE CUP WAS IMPLANTED AND MULTIPLE SCREWS WERE USED TO AUGMENT IT¿S FIXATION. SATISFIED WITH THE CUP A LINER WAS IMPACTED. IT WAS THEN NOTICED THE ACCOLADE CEMENTED STEM WAS LOOSE. DOCTOR DECIDED TO RE CEMENT A NEW STEM INTO THE EXISTING MANTLE. A TRIAL HEAD WAS USED TO CHECK STABILITY. A NEW HEAD WAS IMPLANTED AND THE SURGICAL SITE WAS CLOSED. THE SURGERY WAS PERFORMED WITHOUT INCIDENT. NO FURTHER INFORMATION IS AVAILABLE DUE TO EMR PASSWORD SECURED.
Patient problems: Fall; Inadequate Osseointegration; Injury
MAUDE report 10444634 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page