MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISC CONDYLE KIT W ALIGNMENT PROSTHESIS, ELBOW

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(6). Concomitant: unknown, unknown srs humeral component, unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. 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 - 01190.

Event Description

It was reported that during an elbow surgery the screws did not thread easily into the humeral body assembly after the elbow implant was reduced. The surgeon indicated that he tried two more screws for final assembly and had the same issue but was able to screw down the screws to complete the surgery. Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable. Zimmer biomet does not have reporting responsibility for the condyle kit so that report was submitted in error. Zimmer biomet has reported the event on 0001825034-2018-01190.

• Brand Name: DISC CONDYLE KIT W ALIGNMENT
• 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: 7286039
• MDR Text Key: 100791428
• Report Number: 0001825034-2018-01189
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK013042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 114990
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/19/2018
• 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