MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-36 STD HMRL BRNG; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	N/A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: poland.D10 narrative: item: 115313, lot: j7817476, item name: comp rvsr shldr glnsp +3 36mm.Item: 405800, lot: 65757006, item name: comp.Rev shldr 9 in steinmann.Item: 118001 lot: j7569386 item name: versa-dial/comp ti std taper.Item: 115370 lot: 66917424 item name: comp rvs tray co 44mm.Item: 113648 lot: 66226600 item name: comp primary stem 8mm std.Item: 115330 lot: 66350698 item name: comp rvrs shdr glen bsplt +ha.Item: 115395 lot: 66494759 item name: comp rvs cntrl 6.5x25mm st/rst.Item: 180550 lot: 66579653 item name: comp lk scr 3.5hex 4.75x15 st.Item: 180551 lot: 66602907 item name: comp lk scr 3.5hex 4.75x20 st.Item: 180551 lot: 66783776 item name: comp lk scr 3.5hex 4.75x20 st.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.
Event or Problem Description
It was reported that the patient was implanted with a shoulder system.Subsequently, the patient was revised due to dislocation.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.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the event.The initial report was forwarded in error and should be voided.The event was reported under mfr-0001825034-2024-03093 and mfr-0001825034-2025-01319.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the event.The initial report was forwarded in error and should be voided.

• Brand Name: ARCOM XL 44-36 STD HMRL BRNG
• 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: 21047296
• Report Number: 0001825034-2024-03094
• Device Sequence Number: 3279389
• Product Code: PHX
• UDI-Device Identifier: 00880304475427
• UDI-Public: (01)00880304475427(17)290904(10)66831643
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 06/03/2025

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: XL-115363
• Device Lot Number: 66831643
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male