MAUDE Adverse Event Report: BIOMET ORTHOPEDICS FIXED LOCKING SCREW 3.5 HEX; PROSTHESIS, SHOULDER

Catalog Number 180550

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 10/21/2016

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 5 mdrs filed for the same patient (reference 1825034-2016-04938 / 04942 / 04944 / 04945).Quantity - 2.Concomitant products: catalog #113609, comprehensive primary stem 9mm, lot #920270; catalog #115370, comprehensive reverse tray 44mm, lot #377200; catalog #115310, comprehensive reverse shoulder glenosphere, lot #215200; catalog #xl-115363, arcom xl humeral bearing, lot #839540.

Event Description

It is reported that the patient underwent shoulder arthroplasty revision due to the mini baseplate and taper adaptor disassociating and the screws loosening from the glenoid.

Manufacturer Narrative

This follow-up report is being filed to relay additional and corrected information, which was unknown at the time of the initial medwatch.Current information is insufficient to permit a conclusion as to the cause of the event.

• Brand Name: FIXED LOCKING SCREW 3.5 HEX
• 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: 6138116
• MDR Text Key: 61228525
• Report Number: 0001825034-2016-04943
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 180550
• Device Lot Number: 149470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 60