MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X30MM ST/RST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	115396
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).Item: 010000589.Lot #: 66160344.Item number: comp rvrs 25mm bsplt ha+adptr.The product will not be evaluated by zimmer biomet as it remains implanted in the patient.Once the investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that the patient was revised due to disassociation and it was noted during the revision that the polyethylene bearing was also worn out.The glenosphere and bearing were removed and replaced.There was harm or injury to patient as the patient had to underwent additional surgical procedure.Due diligence is complete.No additional information is available.
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 record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event is not 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 CNTRL 6.5X30MM ST/RST
• 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: 21718105
• Report Number: 0001825034-2025-00864
• Device Sequence Number: 19962060
• Product Code: PHX
• UDI-Device Identifier: 00880304677081
• UDI-Public: (01)00880304677081(17)340306(10)66526933
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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 Catalogue Number: 115396
• Device Lot Number: 66526933
• 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: 03/17/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male