MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK TRAY; PROSTHESIS, SHOULDER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: unk screw cat#: ni, lot#: ni; unk glenoid cat#: ni, lot#: ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02845.

Event Description

It was reported the patient underwent a shoulder arthroplasty.Approximately one month later, the patient alleges the scapula bone was fractured with a 10in fracture and 1in displacement.Further, an unknown screw was alleged to be fractured within the shoulder joint.As a result of the bone fracture, the patient underwent a procedure on an unknown date in 2019 to have 2 plates and over 20 screws implanted.Finally, the patient alleges that to date there is still a fracture at the anterior portion of the scapula bone and the glenoid implant is fractured with the fractured screw still being retained.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that there was no problem found with the device.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that there was no problem found with the device.The initial report was forwarded in error and should be voided.

• Brand Name: UNK TRAY
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10378354
• MDR Text Key: 202009824
• Report Number: 0001822565-2020-02846
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention