MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HUMERAL STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 - 00290, 0001822565 - 2020 - 00291, 0001822565 - 2020 - 00292.

Event Description

It was reported that a patient underwent a left total shoulder on an unknown date.Subsequently, the patient was revised and converted to reverse shoulder due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is 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 HUMERAL STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9631350
• MDR Text Key: 176382351
• Report Number: 0001822565-2020-00289
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GLENOID CAT#NI LOT#NI; UNKNOWN GLENOID POST CAT#NI LOT#NI; UNKNOWN HUMERAL HEAD CAT#NI LOT#NI; UNKNOWN GLENOID CAT#NI LOT#NI; UNKNOWN GLENOID POST CAT#NI LOT#NI; UNKNOWN HUMERAL HEAD CAT#NI LOT#NI
• Patient Outcome(s): Hospitalization; Required Intervention