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)

Device Problems Decoupling (1145); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 03/24/2023

Event Type  malfunction  

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 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.

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)
• Type of Device: 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
• MDR Text Key: 314260200
• Report Number: 1220246-2023-06623
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867234222
• UDI-Public: 00888867234222
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other