MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 40MM VIT E LINER +0MM; SHOULDER, PROSTHESIS

Model Number 00-4350-040-00

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 04/17/2023

Event Type  Injury  

Event Description

It was reported that the patient was revised due to baseplate disassociation, liner wear and pain. no additional patient consequences were reported.  attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2023 -01349.D10: base plate uncemented 25 mm post length cat: 00436202500 lot: 64610507.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon further review, it was determined that the disassociation is between the glenosphere and the baseplate.The liner is not related to the event.This event will be investigated on medwatch#s:0001822565 -2023 -02618; 0001822565 -2023 -01349.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: 40MM VIT E LINER +0MM
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16953156
• MDR Text Key: 315467751
• Report Number: 0001822565-2023-01360
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024269422
• UDI-Public: (01)00889024269422(17)270501(10)65226145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133378
• 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
• Report Date: 09/22/2023

1 Device was Involved in the Event

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 Model Number: 00-4350-040-00
• Device Catalogue Number: 00435004000
• Device Lot Number: 65226145
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2022
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 99 KG