MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL)

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 04/29/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, it was reported by a sales representative via phone that a patient had a left shoulder rtsa on (b)(6) 2020.On (b)(6) 2022, patient underwent a revision surgery due to chronic instability of the glenoid, which appeared to be worn out.However, sales representative could not confirm if any of the arthrex implanted devices had broken.During the revision surgery on (b)(6) 2022, an ar-9560-24 univers revers baseplate, ar-9561-25s univers revers central screw, an ar-9563-16 univers revers peripheral screw, an ar-9563-24 univers revers peripheral locking screw, an ar-9564-2433-lat univers revers glenosphere, an ar-9502f-36cpc univers revers suture cup, and an ar-9503-3633-3c univers revers constrained combo humeral insert were removed.Surgeon did not remove the univers revers stem that was implanted during original procedure on (b)(6) 2022.To complete the revision surgery, an ar-9502-36arca univers revers ca humeral head adapter and an ar-9550-19rca univers revers ca humeral head were implanted successfully.

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.

• Brand Name: UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL)
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 14469029
• MDR Text Key: 292471950
• Report Number: 1220246-2022-04944
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867234192
• UDI-Public: 00888867234192
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• 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, 36 (NEUTRAL)
• Device Catalogue Number: AR-9502F-36CPC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other