MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVS HMRL TI TRAY 44MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 10/13/2014

Event Type  Injury  

Event Description

It was reported patient underwent a comprehensive reverse shoulder arthroplasty on an unknown date.Subsequently, the patient was revised in 2012 due to a fractured humeral tray trunion.The patient underwent a second revision procedure on (b)(6) 2014 due to a fractured humeral tray trunion.The stem, tray and bearing were removed and replaced.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: " loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption, excessive weight, and/or excessive unusual and/or awkward movement and/or activity.".

Manufacturer Narrative

This follow-up report is being filed to relay that the revision procedure that took place on (b)(6) 2011 was previously reported on manufacturer report number 1825034-2011-00142.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 3 mdr's filed for the same event (reference 1825034-2014-08297 & 08579 / 08580).

Event Description

It was reported that the patient underwent a comprehensive reverse shoulder arthroplasty on (b)(6) 2009.Subsequently, the patient was revised on (b)(6) 2011 due to a fractured humeral tray trunion.The patient underwent a second revision procedure on (b)(6) 2014 due to a fractured humeral tray trunion.During the procedure, the trunion would not disengage from the stem and the stem could not be removed from the patient's humerus.The humerus was split in order to complete the procedure.The stem, tray and bearing were removed and replaced.A delay greater than 30 minutes occurred.

• Brand Name: COMP RVS HMRL TI TRAY 44MM
• 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: 4196047
• MDR Text Key: 5154497
• Report Number: 0001825034-2014-08297
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 278590
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2010
• 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: 71 YR