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

Catalog Number 113053

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 03/09/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 3 of 4 mdrs filed for the same patient (reference 1825034- 2016-04080/ 05418/ 05419/ 05423).

Event Description

Patient underwent a right shoulder arthroplasty and 14 days post-implantation, the patient experienced 1 mm of glenoid radiolucency in zone 8.The patient also reported inadequate range of motion at 3 weeks and pain, instability, and impingement at the six week post-operative appointment.No revision has been reported to date.

• Brand Name: VERSA-DIAL HUMERAL HEAD PROSTHESIS
• 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: 6216035
• MDR Text Key: 63663613
• Report Number: 0001825034-2016-05419
• 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: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 113053
• Device Lot Number: 605290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 79