MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL 50X24X52 HUM HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 07/27/2016

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 the lot released with no recorded anomaly or deviation.(b)(4).In the instructions for use it is stated under possible adverse effects, "intraoperative and early postoperative complications can include.Temporary or permanent nerve damage resulting in pain or numbness to the affected limb." this is 3 of 5 reports being submitted for the same patient (reference 1825034-2017-00934 / 00938 / 00939 / 00940 / 00942 ).

Event Description

It was reported that the patient experienced pain and impingement at the 6 week followup.At 2 months post-implantation, unusual shoulder pain and mild instability was observed in the operative shoulder.At the 3 month followup, further mobility issues, instability, and impingement were reported.Four months post-operatively, the subject was diagnosed with a subscapularis tear, and two weeks after this diagnosis, the subject underwent a pectoralis tendon transfer procedure.No further information is available.

• Brand Name: VERSA-DIAL 50X24X52 HUM HEAD
• 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: 6367734
• MDR Text Key: 68609401
• Report Number: 0001825034-2017-00939
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 113055
• Device Lot Number: 792010
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• 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: 65 YR
• Patient Weight: 105