MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVRS SHDR GLEN BSPLT +HA; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 05/28/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial reverse total shoulder arthroplasty on (b)(6) 2012.Subsequently, patient was revised on (b)(6) 2013 due to unknown reasons.The stem, tray, and bearing were replaced.Patient was revised again on (b)(6) 2015 due to glenoid fracture.The tray, bearing, baseplate, and glenoid were replaced.It is unknown what caused the fracture.

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: "intraoperative or postoperative bone fracture and/or postoperative pain." this report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2015-02519 & 02520).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

• Brand Name: COMP RVRS SHDR GLEN BSPLT +HA
• 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: 4835947
• MDR Text Key: 21845400
• Report Number: 0001825034-2015-02520
• 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,Followup,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 115330
• Device Lot Number: 641280
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2012
• 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