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

Model Number	XL-115363
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: comp rvrs 25mm bsplt ha+adptr: catalog#010000589, lot#968640.Unknown comprehensive reverse glenosphere: catalog#ni, lot#ni; unknown.Comprehensive reverse humeral tray: catalog#ni, lot#ni.Comp primary stem 15mm mini: catalog#113635; lot#161830.G2: foreign: united kingdom.Multiple mdr reports have been filed for this report, please see associated reports: 0001825034-2023-01460; 0001825034-2023-01461; 0001825034-2023-01463 and 0001825034-2023-01464.Diligence is in progress to determine whether the product will be returning to zimmer biomet for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial shoulder replacement surgery.Subsequently, approximately four (4) years post-implantation the patient underwent revision surgery to improve function and relieve pain.Due diligence is in progress for this event; to date no further information has been reported.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
Exact implantation date is unknown however is noted to have occurred years prior after concomitant device manufacturing date, between (b)(6)2 019 and (b)(6) 2019.D10: medical product: comp rvrs 25mm bsplt ha+adptr: catalog#010000589, lot#968640; unknown comprehensive reverse glenosphere: catalog#ni, lot#ni; unknown comprehensive reverse humeral tray: catalog#ni, lot#ni; comp primary stem 15mm mini: catalog#113635; lot#161830; unknown fixation screw: catalog#ni, lot#ni, qty#(b)(4) additional reports have been filed for this event.Please see additional reports: 0001825034-2023-01934; 0001825034-2023-01935; 0001825034-2023-01936; 0001825034-2023-01937.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.This complaint 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.

• Brand Name: ARCOM XL 44-36 STD HMRL BRNG
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 17239743
• Report Number: 0001825034-2023-01462
• Device Sequence Number: 12439495
• Product Code: PHX
• UDI-Device Identifier: 00880304475427
• UDI-Public: (01)00880304475427(17)231218(10)416770
• 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 Explanted Year: 2023
• 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): 08/18/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2023
• Device Model Number: XL-115363
• Device Catalogue Number: XL-115363
• Device Lot Number: 416770
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2018
• 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; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose