UNK Shoulder Metaglene
Received Jul 31, 2026 · Event occurred Jan 1, 2026
Report 1818910-2026-13114 · MDR key 50104890
Device
Generic name
Shoulder Metaglene
Manufacturer
Depuy Orthopaedics Inc UsProduct problems
- Osseointegration Problem
Patient
Unknown
- Inadequate Osseointegration
Narrative
Description of Event or Problem
It was reported that an Orthopaedic Surgeon did a clinic consultation with the patient discovering the Glenoid component is loose. This operation was performed 10-20 years ago. Glenoid/scapula bone fracture, metaglene and screws loosening and the screw implant fracture occurred. The intent will be to revise it within a month.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (b)(4).This report is being submitted pursuant to the provisions of 21 CFR, Part 803 (and/or Part 4, as applicable). This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by DePuy Synthes, or its employees that the report constitutes an admission that the product, DePuy Synthes, or its employees caused or contributed to the potential event described in this report. Additional Narrative:D4: UDI: As the catalog/model number was not provided, the (01)GTIN is not available.If information is obtained that was not available for the initial MedWatch, a Follow-up MedWatch will be filed as appropriate.