MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COMPREHENSIVE REVERSE HUMERAL TRIAL; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Product location is unknown.

Event Description

It was reported that a patient underwent a shoulder revision approximately five months post-implantation.During the revision, while reducing and trialing range of motion for the humeral trial, the humeral trial fractured.The surgeon removed all pieces and patient did not retain a foreign body.There were no patient consequences as a result of the malfunction.No further information is available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed from operative reporting.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

• Brand Name: UNKNOWN COMPREHENSIVE REVERSE HUMERAL TRIAL
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7918010
• MDR Text Key: 122171221
• Report Number: 0001825034-2018-08708
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 60 YR