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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Event Description

It was reported patient underwent a right total shoulder arthroplasty on (b)(6) 2014.Subsequently, patient underwent a revision procedure on (b)(6) 2014 due to infection.A further revision procedure has been indicated due to pain; however, no revision procedure has been reported to date.

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 13 states, "intraoperative or postoperative bone fracture and/or postoperative pain." this report is number 9 of 9 mdrs filed for the same event (reference 1825034-2014-03616 / 03623 and 1825034-2015-02144).

• Brand Name: VERSA-DIAL/COMPREHENSIVE 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: 4785623
• MDR Text Key: 22155456
• Report Number: 0001825034-2015-02144
• 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: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 859650
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2014
• 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): Required Intervention