MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL 42X21X43 HUM HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Cervical Changes (1773); Muscular Rigidity (1968); Myalgia (2238)

Event Date 11/10/2016

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.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 is 7 of 10 reports being filed for the same patient (reference 1825034-2017-00576 / 00578 / 00579 / 00581 / 00582 / 00743 - 00747).

Event Description

It is reported that the patient has developed polymyalgia rheumatica in an unspecified shoulder and some cervical disease approximately 5 years subsequent to shoulder arthroplasty.

• Brand Name: VERSA-DIAL 42X21X43 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: 6342795
• MDR Text Key: 67801125
• Report Number: 0001825034-2017-00744
• 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: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 113034
• Device Lot Number: 646320
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2009
• 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: 81 YR
• Patient Weight: 61