MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No device or photos were returned for evaluation.The device history records were reviewed for this unit, with no deviations or anomalies being identified.This device is used for treatment.A definitive root cause of the reported issue cannot be determined with the information provided.Multiple mdr reports were filed for this event, please see associated reports: 1825034-2016-03696 / 03694 / 03695, and 0001825034-2017-01394 / 01395/ 01403.

Event Description

It was reported that the patient experienced pain, instability, moderate supraspinatus/greater tuberosity tenderness, mild acromioclavicular joint tenderness, mild biceps tendon tenderness, impingement, and subacromial crepitus noted at six weeks post-operative follow-up.Continued pain, instability, mild biceps tendon tenderness, and subacromial crepitus noted at three month post-operative follow-up.Subsequently, pain, instability, mild acromioclavicular joint tenderness were noted to persist into one year post-operative follow-up.No revision has been reported to date.No additional patient consequences were reported.

• Brand Name: VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR
• 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: 6440505
• MDR Text Key: 71093815
• Report Number: 0001825034-2017-01393
• 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: Physician
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• 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: 800650
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2015
• 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 Weight: 151