MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXT-C/M ELBOW-ULNAR; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Loss of Range of Motion (2032)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Reported event was confirmed as visual inspection of pictures identified blood on devices.Wear was observed on the bearing.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01353.

Event Description

It was reported that the patient underwent a coonrad morrey elbow arthroplasty.Subsequently, the patient had a reduced range of movement and slight wear on the lateral side of the ulna bearing.The patient's bearings and bushing were revised.No additional patient consequences were reported.

• Brand Name: EXT-C/M ELBOW-ULNAR
• 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: 12224907
• MDR Text Key: 263424714
• Report Number: 0001822565-2021-02050
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 07/01/2021
• 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
• Treatment: UNKNOWN BUSHING KIT
• Patient Outcome(s): Required Intervention