Unknown Proximal Humeral
Received Jul 31, 2026 · Event occurred Jul 3, 2026
Report 0001825034-2026-02217 · MDR key 50097001
Device
Generic name
Elbow, Prosthesis
Manufacturer
Zimmer Biomet, Inc.Catalog number
Unknown Proximal Humeral
Lot number
Unknown
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Insufficient Information
Narrative
Description of Event or Problem
It was reported patient underwent a revision post implantation due to unknown reason. Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4)D10: Item # Unknown, Unknown Distal Humeral Component, Lot # UnknownItem # Unknown, Unknown Humeral Head, Lot # UnknownItem # 211226, COMPR SRS IC SEG - 90MM, Lot # 66983195Item # Unknown, Unknown Assembly, Lot # UnknownH6: Proposed Component Code - Mechanical (G04) - StemThe device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental MedWatch 3500A will be submitted.