MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 39 (+2 RIGHT); SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS REVERS SUTURE CUP, 39 (+2 RIGHT)
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One unpackaged ar-9502f-39rcpc univers revers suture cup, 39 (+2 right) batch 19.03200 was received for evaluation.Visual evaluation of the suture cup revealed discoloration marks on the device surface and regular signs of wear.The returned mating screw showed damage to the screw hex.It was concluded that the observed damage to the devices could most likely be attributed to the fact that they were implanted and then removed.Functional testing included attaching the ar-9502f-39rcpc univers revers suture cup, 39 (+2 right) batch 19.03200, with the returned ar-9501-14s to test the fixation of the suture cup to the univers revers apex humeral stem size 14.The test concluded that no issues were found with the fixation of the device.The ar-9502f-39rcpc univers revers suture cup, 39 (+2 right) batch 19.03200 is firmly attached to the humeral stem.And no problems were encountered when they were separated.The most likely cause of the reported failure is a patient-specific event.More specifically, according to the event description, the patient had to undergo revision surgery due to an injury unrelated to the device¿s functionality or performance.No allegations were identified against the ar-9502f-39rcpc univers revers suture cup, 39 (+2 right), batch 19.03200; however, the returned screw was damaged.
Event or Problem Description
On 11/13/2024, it was reported by a facility representative via email that arthrex devices were explanted from a patient.No additional information was provided.Additional information received on 11/25/2024: the patient underwent a total shoulder arthroplasty, rotator cuff repair, capsular release procedure on (b)(6) 2024.A 24mm glenoid univers revers baseplate, a 35mm central univers revers screw, a 5.5 x 28mm peripheral lock univers revers screw, a 5.5 x 32mm peripheral lock univers revers screw, a 5.5 x 16mm peripheral lock univers revers screw, a 5.5 x 16mm peripheral lock univers revers screw, a 24 x 39mm 4 lat taper univers revers glenosphere, a 39 2mm revers shoulder cup, a 14 apex univers revers stem, a 39 3 revers shoulder liner, and a 39 6mm revers shoulder humeral spacer were implant.Due to an injury the patient underwent revision surgery and had the 35mm central univers revers screw, the 5.5 x 28mm peripheral lock univers revers screw, and the 5.5 x 32mm peripheral lock univers revers screw remov.

• Brand Name: UNIVERS REVERS SUTURE CUP, 39 (+2 RIGHT)
• 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: 21399638
• Report Number: 1220246-2025-00465
• Device Sequence Number: 9455936
• Product Code: HSD
• UDI-Device Identifier: 00888867234246
• UDI-Public: (01)00888867234246(11)200201(17)250131(10)19.03200
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: UNIVERS REVERS SUTURE CUP, 39 (+2 RIGHT)
• Device Catalogue Number: AR-9502F-39RCPC
• Device Lot Number: 19.03200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2020
• 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: Other
• Patient Sex: Unknown