MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL 54X24X58 HUMERAL HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

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

Event Date 02/28/2014

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 6 states, ¿inadequate range of motion due to improper selection or positioning of components.¿ number 13 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿ no product was not returned and therefore the root cause could not be determined this report is number 1 of 5 mdrs filed for the same patient (reference 1825034-2017-00385 / 00386 / 00387 / 00388 / 00389).

Event Description

A clinical patient underwent a right shoulder arthroplasty and this patient has reported on going pain, instability and stiffness in the right operative shoulder since approximately 18 days post-implantation with some improvement in pain and instability approximately six months post-implantation but with some stiffness still reported.At approximately one year post-implantation, the patient reported experiencing pain and instability with the stiffness having diminished.No revision has been reported to date and no more information has been received.

• Brand Name: VERSA-DIAL 54X24X58 HUMERAL 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: 6356044
• MDR Text Key: 68223566
• Report Number: 0001825034-2017-00385
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 113065
• Device Lot Number: 521570
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2016
• Initial Date FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2013
• 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: 48 YR
• Patient Weight: 123