Osteolock 5260-5-050Recalls & reported problems
Howmedica Osteonics Corp. · 3.5mm Hex Drive Head Cancellous Screw · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 07613327035759), received between Aug 24, 2020 and Apr 12, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Degraded” (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.
Reports received per month
Most reported problems
Device problems
- Degraded1
- Fracture1
Patient problems
- Inadequate Osseointegration1
- Metal Related Pathology1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 12, 2024Degraded; Degraded
TOTAL HIP REVISION. ACETABULAR CUP, MDM LINER AND MDM INSERT. UPDATE PER MEDICAL RECORDS RECEIVED: THE PATIENT WAS REVISED DUE TO LOOSENING OF THE ACETABULAR COMPONENT AND METALLOSIS.
Patient problems: Inadequate Osseointegration; Metal Related Pathology; Pain
MAUDE report 19096121 ↗MalfunctionAug 24, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING A RIGHT HIP REVISION (MANUFACTURER OF REVISED DEVICES UNKNOWN), A SCREW WAS ALMOST COMPLETELY SEATED WHEN THE HEAD OF THE SCREW BROKE OFF. THE HEAD WAS REMOVED, THE REMAINDER OF THE SCREW WAS LEFT IN THE PATIENT, ANOTHER SCREW WAS NOT IMPLANTED. PROCEDURE COMPLETED SUCCESSFULLY WITH NO DELAY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10444587 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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