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

Model Number	UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL)
Medical Device Problem Codes	Decoupling (1145); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that 6 months after the initial surgery the implanted cub became detached from the shaft.A revision universe reverse surgery was therefore performed and a new cup with the same part number was implanted with an 155° inclination to resolve the issue.
Additional Manufacturer Narrative
-one unpackaged ar-9502f-39cpc was received for investigation.-visual evaluation noted scratches around the device, also the threads are damaged.The device was returned with the matting part assembled and also scratched.The most likely cause of this complaint is that the surgeon/patient does not properly follow the direction for use.(8.Failure to achieve the appropriate torque requirements when tightening locking screws may result in the premature loosening of the device).-refer to investigation photos.-complaint is confirmed.

• Brand Name: UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL)
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16838563
• Report Number: 1220246-2023-06623
• Device Sequence Number: 6823878
• Product Code: HSD
• UDI-Device Identifier: 00888867234222
• UDI-Public: 00888867234222
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 08/31/2026
• Device Model Number: UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL)
• Device Catalogue Number: AR-9502F-39CPC
• Device Lot Number: 21.01701
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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