MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER SYSTEM PRIMARY REVISION LENGTH SHOULDER STEM 6MM X 194MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 12/19/2016

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption and/or excessive activity." medical product ¿ reverse mini baseplate, catalog#: 010000859 lot#: 226910; glenosphere, catalog#: 115310 lot#: 415250; humeral bearing, catalog#: xl-115363 lot#: 386500; central screw, catalog#: 115396 lot#: 094560; locking screws, catalog#: 180551 lot#: 294160, 706150, 030040; locking screw, catalog#: 180550 lot#: 542000; comp rvs tray co 44mm, catalog#: 115370 lot#: 919490.Therapy date - (b)(6) 2016.

Event Description

Patient underwent a shoulder revision approximately nine months post-implantation due to loosening of the humeral component.The stem, and humeral bearing and tray were removed and replaced.

• Brand Name: COMPREHENSIVE SHOULDER SYSTEM PRIMARY REVISION LENGTH SHOULDER STEM 6MM X 194MM
• 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: 6228653
• MDR Text Key: 64043681
• Report Number: 0001825034-2017-00070
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 113666
• Device Lot Number: 849400
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2011
• 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: 76 YR