MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN BIO-MODULAR GLENOID; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Tissue Damage (2104); No Information (3190)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).The customer has not yet indicated if the device will be returned to zimmer biomet for evaluation, as the device remains implanted.An investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient had an initial right shouder arthroplasty on unknown date.Subsequently, custom components were requested for revision due to unknown reasons on an unknown date.No revision has been reported and no further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Initial implant date - unknown date, 1998.

Event Description

It was reported that the patient underwent a right shoulder arthroplasty revision due to rotator cuff failure approximately eighteen (18) years after primary implantation of an anatomical shoulder.Glenoid articular surface was replaced with a custom-made glenoid assembly, a new humeral stem, tray, and bearing.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Complaint history review was unable to be performed, as the part number and lot number are unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN BIO-MODULAR GLENOID
• 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: 6511320
• MDR Text Key: 73371017
• Report Number: 0001825034-2017-02672
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention