MAUDE Adverse Event Report: ARTHREX, INC. REVERS CA HUMERAL HEAD, 50/19; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	REVERS CA HUMERAL HEAD, 50/19
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 6/23/2022, it was reported by a sales representative via phone that during a revision procedure, both the ar-9502-29arca, revers 39mm ca adapter assembly and, ar-9550-29rca, revers ca humeral head, 50/19, were having issues seating.The surgeon had them in the suture cup and then after trial reduction, they were augmenting the subs cap and did an internal rotation.The adaptor and head, both, popped out of the cup.The head became stuck on the post and the adaptor would not sit in the cup.In order to be safe it was agreed that a new implant be used to complete the case.The surgeon had no issues after swapping out the implants, however, it did add time to the case.The revision was a conversion from a revers total shoulder procedure to a hemi due to the mgs being loose and not holding in the glenoid.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is not confirmed.(1) unpackaged ar-9550-19rca was received for evaluation alongside (1) ar-9502-39rca stuck to an ar-9660-r.Visual inspection of the ar-9550-19rca revealed no apparent issues.Mating to the ar-9502-39rca was successful, and separation was accomplished with some level of resistance as expected.

• Brand Name: REVERS CA HUMERAL HEAD, 50/19
• Common Device Name: SHOULDR PROSTH HEMI- HUM UNCEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19290044
• Report Number: 1220246-2024-03122
• Device Sequence Number: 12946521
• Product Code: HSD
• UDI-Device Identifier: 00888867229532
• UDI-Public: 00888867229532
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K151527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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: 01/31/2025
• Device Model Number: REVERS CA HUMERAL HEAD, 50/19
• Device Catalogue Number: AR-9550-19RCA
• Device Lot Number: 10634232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• 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
• Patient Sex: Unknown