MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD W/VARIABLE OFFSET; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 03/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has not indicated whether or not the product will be returned to zimmer biomet for investigation, as the device remains implanted at this time.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: 0001825034-2017-02810, 02812, 02814, and 02816.

Event Description

It was reported that the patient underwent an initial left total shoulder arthroplasty.Subsequently, the patient had supraspinatus atrophy noted at six (6) week post-operative follow-up.Additionally, anterior instability was noted at three (3) month post-operative follow-up, however was resolved by one year post-operative follow-up.Glenoid radiolucency was additionally noted at one year post-operative follow-up.The condition remains tolerated.No additional patient consequences reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of provided xrays.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.X-ray review confirmed glenoid radiolucency.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: VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD W/VARIABLE OFFSET
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6528404
• MDR Text Key: 73898258
• Report Number: 0001825034-2017-02813
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• 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: 113044
• Device Lot Number: 389740
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 77