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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); No Information (3190)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04928, 0001825034 - 2019 - 04925, 0001825034 - 2019 - 04927.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.

Event Description

It was reported that the patient was revised due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that the patient was revised due to periprosthetic humeral bone fracture.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

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.

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 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.

Event Description

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

• Brand Name: UNKNOWN STEM
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9261682
• MDR Text Key: 164493719
• Report Number: 0001825034-2019-04928
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GLENOID; UNKNOWN HUMERAL HEAD; UNKNOWN GLENOID; UNKNOWN HUMERAL HEAD
• Patient Outcome(s): Hospitalization; Required Intervention