MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 08/14/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.¿ device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.This report is number 2 of 3 mdrs filed for the same event (reference 1825034-2015-04011 / 04012 / 04013).

Event Description

It was reported that the patient underwent left total reverse shoulder arthroplasty on (b)(6) 2015.Subsequently, patient was revised on (b)(6) 2015 due to disassociation of the glenosphere from the baseplate.The reverse tray, bearing, glenosphere, and taper adapter were removed and replaced.Additionally, the patient was revised a second time on (b)(6) 2015 due to the disassociation of the glenosphere from the baseplate.The reverse tray, bearing, glenosphere, taper adapter, baseplate, and screws were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

• Brand Name: VERSA-DIAL/COMP TI STD TAPER
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5091664
• MDR Text Key: 26353810
• Report Number: 0001825034-2015-04012
• 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
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 434730
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR