MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISC CONDYLE PROV MALE/FEMALE; PROSTHESIS,

Model Number N/A

Device Problems Degraded (1153); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products 414806 discovery prov lock screw unknown.414877 disc 4x75mm right ulna trial 7555919.414837 disc 5x100mm right hum trial 7555023.(b)(6).Locking screws along with the humeral and ulna trial are returned for evaluation; functional check confirmed the screw would not come out of the device.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-00046, 0001825034-2019-05640.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during the elbow arthroplasty the screw could not be disengaged from the trails after trial reduction.No impact to the patient or surgery was noted.A delay of 15- 30 mins was noted.No additional information is available at this time.

• Brand Name: DISC CONDYLE PROV MALE/FEMALE
• Type of Device: PROSTHESIS,
• 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: 9588763
• MDR Text Key: 190987198
• Report Number: 0001825034-2019-05640
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 414896
• Device Lot Number: 145780
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1