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

Catalog Number 110027734

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2023

Event Type  Injury  

Event Description

It was reported that the patient has been indicated for a revision due to unknown reasons.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).G2: foreign: japan.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were 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

It was reported patient was revised due to fracture and dislocation of the glenoid approximately 5 months post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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

It was reported patient is being considered for a pmi product due to fracture and dislocation of the glenoid.No revision has been reported to date.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon further review it has been determined that the device was previously investigated on medwatch#: 0001825034-2023-01969.This file will be considered not reportable.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

Upon further review it has been determined that the device was previously investigated on medwatch#: 0001825034-2023-01969.This file will be considered not reportable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00886; 0001825034-2024-00887; 0001825034-2024-00888; 0001825034-2024-00889; 0001825034-2024-00890.D10: unknown screw qty (b)(4).Unknown glenosphere.Unknown bearing.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

It was reported patient was revised due to fracture of the glenoid and dislocation of the bearing and glenopshere approximately 5 months post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN GLENOID
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18129934
• MDR Text Key: 328028337
• Report Number: 0001825034-2023-02662
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304818934
• UDI-Public: (01)00880304818934(17)240107(10)66157394
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/04/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2024
• Device Catalogue Number: 110027734
• Device Lot Number: 66157394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 12/21/2023; 01/30/2024; 03/05/2024; 04/03/2024
• Supplement Dates FDA Received: 01/12/2024; 02/26/2024; 04/01/2024; 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Sex: Female