MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP CONV GLEN LINER E1; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Entrapment of Device (1212); Unstable (1667)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a shoulder arthroplasty on (b)(6) 2015.During the closing, the surgeon noticed instability and decided to switch to reverse components.Given the convertible nature the of baseplate, it was able to remain in place.The liner and head were simply removed, and replaced with reverse components.While trailing for the reverse components, the taper adapter trial from the total shoulder instrument set became wedged into the implanted baseplate.The trial taper adapter was removed with a curved osteotome and mallet.This did not result in a delay greater than 30 minutes or additional preparation.

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 or deviation.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-02815 & 02816).

• Brand Name: COMP CONV GLEN LINER E1
• 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: 4888990
• MDR Text Key: 6263398
• Report Number: 0001825034-2015-02815
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130390
• 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: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 110005237
• Device Lot Number: 398110
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention