Alumina 17-3605ERecalls & reported problems
Howmedica Osteonics Corp. · Alumina Ceramic C-Taper Femoral Head · Class 2 · Implant
All models of Alumina (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327101201), received between Apr 24, 2019 and Apr 20, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break1
- Noise, Audible1
Patient problems
- Ambulation or Postural Difficulties1
- Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2022Noise, Audible; Noise, Audible
AS REPORTED: "LEFT REVISION HIP REPLACEMENT SURGERY. SURGEON COMMENT: PATIENT COMPLAINED OF 'SQUEAKING.'" AN ALUMINA HEAD AND LINER WERE REVISED TO A BIOLOX HEAD AND SLEEVE AND A POLY INSERT.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 14160177 ↗InjuryApr 24, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SHATTERING OF THE 36 +5 ALUMINA FEMORAL HEAD (POSSIBLE CAUSE OR CONTRIBUTOR TO IMPLANT DAMAGE NOT REPORTED TO REP). THE HEAD, INSERT, AND SLEEVE WERE REVISED TO LIKE DEVICES (REVISION HEAD WAS BIOLOX). REP CONFIRMED THERE WAS NO DAMAGE TO AND NO ALLEGATIONS AGAINST THE LINER OR SLEEVE. REP PROVIDED THE PRIMARY OPERATIVE AND IMPLANT REPORTS, PRE-REVISION X-RAYS, AND REVISION IMPLANT SHEET AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Injury
MAUDE report 8546777 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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