MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 40MM ÿ +6MM OFFSET POLY LINER; SHOULDER, PROSTHESIS

Model Number 00-4349-040-06

Device Problems Unstable (1667); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 02/07/2023

Event Type  Injury  

Event Description

It was reported that the patient's shoulder was unstable.Subsequently, the patient was revised due to disassociation.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 - 00610.12mm humeral stem spacer cat: 00434903912 lot: 63455140, 40mm ã¿ glenosphere cat: 00434904011 lot: 64844921.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.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: 40MM ÿ +6MM OFFSET POLY LINER
• 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: 16502229
• MDR Text Key: 310873187
• Report Number: 0001822565-2023-00599
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024633100
• UDI-Public: (01)00889024633100(17)270430(10)64163191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

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: 00-4349-040-06
• Device Catalogue Number: 00434904006
• Device Lot Number: 64163191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2019
• 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): Required Intervention; Hospitalization
• Patient Sex: Male