MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS TRAY CO 44MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 1 day post implantation, the patient experienced disassociation of the glenosphere.Subsequently, the patient was revised, during which it was noted that there was still some bone around the humeral stem which prevented the full seating of the humeral tray, leading to disassociation.The central screw was also found to have disengaged.The tray, poly, and glenosphere were revised.Attempts have been made and no additional information is available.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: united kingdom.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to user error.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.The reported event is unable to be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information is available regarding the incident.

• Brand Name: COMP RVS TRAY CO 44MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 20249435
• Report Number: 0001825034-2024-02228
• Device Sequence Number: 7235120
• Product Code: PHX
• UDI-Device Identifier: 00880304543201
• UDI-Public: (01)00880304543201(17)340603(10)66724754
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115370
• Device Lot Number: 66724754
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose