INSTRUMENT 1020-2735Recalls & reported problems
Howmedica Osteonics Corp. · ACCOLADE NECK TRIAL · Class 2
All models of INSTRUMENT (131)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327208252), received between Jun 5, 2018 and Jun 5, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delamination” (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
- Delamination1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2018Fracture; Delamination; Fracture; Delamination
COLOR MARKING FROM THE RASPS CRUMBLE OFF. REPLACEMENT WAS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7569342 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, uncemented devices
- LFIT 6260-9-136Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented166 reports
- Trident 623-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented112 reports
- Accolade 6021-0435Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented88 reports
- EXETER 0580-1-044Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 recall22 reports
- Endo-Model SL Knee Prosthesis System 16-2840/02WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall17 reports
- Endo-Model SL Knee Prosthesis System 16-2840/05WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall12 reports
- Trident 623-10-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented57 reports
- LFIT 6260-9-336Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented56 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.
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