MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOM XL 44-36 STD +3 HMRL BRG; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 08/23/2011

Event Type  Injury  

Event Description

It was reported patient underwent a shoulder hemiarthroplasty on (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2009 due to an unknown reason.A comprehensive reverse shoulder system was implanted.Patient underwent an additional procedure on (b)(6) 2010 implanting a comprehensive reverse shoulder system.It is unknown if the patient is bilateral.Patient underwent a further revision procedure on (b)(6) 2011 due to an unknown reason.The humeral tray and humeral bearing was removed and replaced.Subsequently, a revision procedure has been indicated due to a fractured humeral tray trunion and the trunion is stuck in the humeral stem; 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 related to the event.This report is number 3 of 4 mdrs filed for the same patient (reference 1825034-2014-08229 / -08361 /-08362 /-08363).

• Brand Name: ARCOM XL 44-36 STD +3 HMRL BRG
• 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: 4199005
• MDR Text Key: 20456202
• Report Number: 0001825034-2014-08362
• 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
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2014
• Device Model Number: N/A
• Device Catalogue Number: XL-115364
• Device Lot Number: 600340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2009
• 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): Hospitalization; Required Intervention