MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXEL ULNAR COMPONENT; PROSTHESIS, ELBOW

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).Concomitant medical products: 211225 compr srs ic seg - 60mm 875550, 211238 compr srs mod stem - 12x100mm 653050, 110029938 compr srs 50mm dst hum bdy rt 213040, unknown nexel ulnar articulation kit.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: 0001822565 - 2018 - 06975.

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 received, it was determined that the event is not related to the procedure or implants.Hence it is not reportable.

Event Description

No additional information is available to report at this time.

• Brand Name: UNKNOWN NEXEL ULNAR COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8221620
• MDR Text Key: 132203786
• Report Number: 0001822565-2018-06974
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 120