MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BUSHING KIT; PROSTHESIS, EXTREMITIES

Model Number N/A

Device Problems Fracture (1260); Unstable (1667); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product(s) unknown humeral component; unknown ulnar component; unknown stems (2).Report source: foreign: event occurred in (b)(6).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.Discarded.

Event Description

It was reported that a patient underwent a replacement of bushing kit.Subsequently, the patient underwent a revision procedure to replace the bushing kit due to wear, fracture and instability.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10 d11 unknown humeral component unknown ulnar component unknown stems (2) unknown bearings the reported event was confirmed by a review of pictures and x-rays.Visual examination of the provided pictures identified that the bushing and pins are explanted and have bloodstains.The bushings appear to be fractured.The prongs of the inner pin are fractured.A review of the x-rays identified implant disassembly of a right total elbow arthroplasty at the hinge mechanism with the fractured pin within the antecubital fossa.Possible fracture of the olecranon and loosening of a radial intramedullary rod.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: 0001822565-2020-00750 h3 other text : discarded.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN BUSHING KIT
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9777031
• MDR Text Key: 191740141
• Report Number: 0001822565-2020-00749
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: EXT-C/M ELBOW-UNKNOWN-BEARING
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention