MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM ÿ +0MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00434906500
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure due to dislocation approximately four years post implantation.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: 0001825034 -2023 -02154.D10: comp rvrs shldr glnsp std 36mm cat: 115310 lot: j7571012.25mm versa-dial taper adaptor cat: 118000 lot: j7500817.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.
Event or Problem Description
It was further reported that the patient was revised due to disassociation.
Additional 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.A review of the device history record(s) identified no deviations or anomalies during manufacturing.Further information received indicates that the patient was revised due to disassociation.Therefore, this product did not cause or contribute to the reported event and should be considered not reportable.The event is addressed on 0001825034-2023-02154.The reported event is unconfirmed.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 36MM ÿ +0MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 17731119
• Report Number: 0001822565-2023-02492
• Device Sequence Number: 12217422
• Product Code: PHX
• UDI-Device Identifier: 00889024269170
• UDI-Public: (01)00889024269170(17)240430(10)63319395
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/14/2023
• 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 00434906500
• Device Lot Number: 63319395
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown