MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVRS SHOULDER GLENOSPHERE STD 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 06/11/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a reverse total shoulder arthroplasty on (b)(6) 2015.Subsequently, patient was revised on (b)(6) 2015 due to disassociation of the glenosphere from the baseplate.It was noted the central screw was left proud during the initial procedure.The humeral bearing, baseplate, and glenosphere were removed and replaced.

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.There are warnings in the package insert that state that this type of event can occur: under warnings it states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-02926).

• Brand Name: COMP RVRS SHOULDER GLENOSPHERE STD 36MM
• 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: 4902767
• MDR Text Key: 19807105
• Report Number: 0001825034-2015-02925
• 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: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 375460
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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