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

Catalog Number	115370
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under: (b)(4).D10 narrative: item: ep-115394, lot: 762670, item name: e1 44-36 std +3 hmrl brg, item: 115310, lot: 176440, item name: comp rvrs shldr glnsp std 36mm.The product will not be evaluated by zimmer biomet as it was discarded.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 implanted with a total shoulder arthoplasty.Subsequently, the patient was revised due to fracture of the humeral tray.There was harm/injury to the patient as the patient had to underwent surgical/medical intervention.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.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.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• 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: 22044501
• Report Number: 0001825034-2025-01450
• Device Sequence Number: 8880183
• Product Code: PHX
• UDI-Device Identifier: 00880304543201
• UDI-Public: (01)00880304543201(17)260527(10)233170
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• 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): 08/27/2025

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 Expiration Date: 05/27/2026
• Device Catalogue Number: 115370
• Device Lot Number: 233170
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2016
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 127 KG