MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X20MM ST/RST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	115394
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: australia.H10 narrative: d10 narrative: item #: 010000589, lot#: 66403651, item name: comp rvrs 25mm bsplt ha+adptr.Item #: 110031399, lot#: 66580871, item name: mini standard thickness +0mm taper offset 40mm diameter humeral tray.Item #: 110031424, lot#: 66394204, item name: standard 36mm diameter bearing.Item #: 180551, lot#: 66501618, item name: comp lk scr 3.5hex 4.75x20 st.Item #: 180552, lot#: 66543392, item name: comp lk scr 3.5hex 4.75x25 st.Item #: 180559 lot#: 66138814 item name: comp nlk scr 3.5hex 4.75x25 st item #: 180550 lot#: 66591598 item name: comp lk scr 3.5hex 4.75x15 st no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record 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
It was reported that the patient underwent a revision surgery due to a loosening of the device.There was harm or injury to patient as the patient had to undergo additional surgical procedure.Due diligence is complete.No additional information is available.

• Brand Name: COMP RVS CNTRL 6.5X20MM 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: 21370135
• Report Number: 0001825034-2025-00358
• Device Sequence Number: 8519188
• Product Code: PHX
• UDI-Device Identifier: 00880304677067
• UDI-Public: (01)00880304677067(17)340109(10)66445625
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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: 115394
• Device Lot Number: 66445625
• 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: 01/31/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2024
• 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: Female