Catalog Number UNK SHOULDER IMPLANT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Loss of Range of Motion (2032); Unspecified Musculoskeletal problem (4535)
|
Event Date 05/06/2022 |
Event Type
Injury
|
Event Description
|
It was reported that the patient had her left shoulder replaced where she had a global unite construct implanted.Over time the patient rotator cuff had torn and function and rom became an issue.The surgeon revised the anatomic construct to a delta reverse.The proximal body, humeral head, and apg were explanted, the stem was left in situ and a delta reverse construct was implanted.There is no reported loosening.No surgical delay reported.Original implant date is unknown.Doi: unknown.Dor: (b)(6) 2022.Affected side: left shoulder.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
|
|
Search Alerts/Recalls
|