Trident 500-11-48DRecalls & reported problems
Howmedica Osteonics Corp. · Hemispherical Acetabular Shell · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540431844), received between Apr 19, 2018 and Dec 7, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Scratched Material1
Patient problems
- Insufficient Information1
- Joint Dislocation1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT BOOKED FOR HIP REVISION SURGERY (PLANNED SURGERY). SURGEON PLANNED FOR A REPLACEMENT OF FEMORAL HEAD. PHOTOS OF EXPLANTED DEVICES INDICATE A CERAMIC HEAD, ALUMINA INSERT AND ACETABULAR SHELL WERE REVISED.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 15930133 ↗MalfunctionApr 19, 2018Scratched Material; Scratched Material
NURSE INFORMED THAT THE INSIDE OF THE SHELL HAS A SCRATCH. CUSTOMER USED ANOTHER SHELL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7442547 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish devices
- Arcos Modular Revision Hip System 11-301310Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 recall9 reports
- Arcos Modular Revision Hip System 11-301342Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 recall4 reports
- Tritanium 502-03-52DHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish39 reports
- V40 Head 6260-5-332Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish12 reports
- V40 Head 6260-9-032Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish11 reports
- EXETER 0580-1-443Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish11 reports
- Trident 509-02-56EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish10 reports
- Taperloc Complete Primary Femoral 51-104180Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.