Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Anemia (1706); Blood Loss (2597)
|
Event Date 10/12/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Udi: (b)(4).Medical devices: 211238 compr srs mod stem - 12x100mm 653050; 110029938 compr srs 50mm dst hum bdy rt 213040; unknown nexel ulnar component; unknown nexel ulnar articluation component.Report source: foreign- (b)(6).The complaint is under investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11333; 0001825034 - 2018 - 11334.
|
|
Event Description
|
It was reported that patient underwent an initial right distal humeral resection with reconstruction involving an elbow arthroplasty, and received blood transfusion due to postoperative anemia.It was mentioned that the event is procedure related and not device related.No other additional information is provided.
|
|
Manufacturer Narrative
|
Upon reassessment of the reported event based on the additional information, it was determined that the product is not reportable.The event is not procedure or implant related.
|
|
Event Description
|
No additional information is available to report at this time.
|
|
Search Alerts/Recalls
|