MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 12MM HUMERAL STEM SPACER; SHOULDER, PROSTHESIS

Catalog Number	00434903912
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a the patient is being considered for a shoulder 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.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02472, 0001822565-2023-02473, 0001822565-2023-02475, 0001822565-2023-02476.D10: 40mm 㿠glenosphere cat: 00434904011 lot: 65243512.14mm 㿠130mm length humeral stem cat: 00434901413 lot: 65242785.40mm 㿠+6mm offset 65⺠neck angle retentive poly liner cat; 00434906606 lot: 64759532.+2mm lateral offset 25mm post length base plate cat: 00434902502 lot: 64759472.Invers/revers scr syst 4.5-48 cat: 01.04223.048 lot: 2940206.Invers/revers scr syst 4.5-42 cat: 01.04223.042 lot: 3082070.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.This subform will be voided as this component did not cause or contribute to the event.The event will be investigated under medwatch#s: 0001822565-2023-02473 and 0001822565-2023-02475.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 or Problem Description
This subform will be voided as this component did not cause or contribute to the event.The event will be investigated under medwatch#s: 0001822565-2023-02473 and 0001822565-2023-02475.

• Brand Name: 12MM HUMERAL STEM SPACER
• Common Device Name: 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: 17723411
• Report Number: 0001822565-2023-02474
• Device Sequence Number: 20608394
• Product Code: HSD
• UDI-Device Identifier: 00889024269125
• UDI-Public: (01)00889024269125(17)320429(10)65473774
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 00434903912
• Device Lot Number: 65473774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male