Unknown Humeral Head
Received Jul 30, 2026 · Event occurred Jul 3, 2026
Report 0001825034-2026-02219 · MDR key 50089737
Device
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 # Unknown,Item # Unknown, Unknown Proximal Humeral Component, Lot # Unknown,Item # 211226, COMPR SRS IC SEG - 90MM, Lot # 66983195,Item # Unknown, Unknown Assembly, Lot # Unknown.H6: Proposed Component Code - Mechanical (G04) - Head.The 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.