MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 39 (+2 LEFT); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number UNIVERS REVERS SUTURE CUP, 39 (+2 LEFT)

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 09/27/2022

Event Type  Injury  

Event Description

On 9/28/2022, it was reported by a sales representative via email that an a patient underwent a reverse modular shoulder procedure on (b)(6) 2020.During this procedure an ar-9501-13s apex humeral stem, an ar-9502f-39lcpc suture cup, an ar-9503m-03 humeral insert, an ar-9560-28-4 modular baseplate, an ar-9561-35s central screw, an ar-9563-36 peripheral locking screw, an ar-9563-40 peripheral locking screw, and an ar-9564-2839-lat glenosphere, were successfully implanted.Two years later, on (b)(6) 2022, patient underwent a revision reverse total shoulder procedure because the central and peripheral screws broke off the baseplate.Additional information received on 9/30/2022: during revision surgery on (b)(6) 2022, an ar-9560-28-4 modular baseplate, an ar-9561-35s central screw, an ar-9563-36 peripheral locking screw, and ar-9563-40 peripheral locking screw, and an ar-9564-2839-lat glenosphere were removed.Procedure was completed by implanting an ar-9502-39arca univers revers ca humeral head adapter from lot number 18.00756 and an ar-9550-19rca univers revers ca humeral head from lot number 10248799 were implanted.

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, 39 (+2 LEFT)
• 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: 15615581
• MDR Text Key: 301852646
• Report Number: 1220246-2022-05627
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867234239
• UDI-Public: 00888867234239
• 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: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• 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, 39 (+2 LEFT)
• Device Catalogue Number: AR-9502F-39LCPC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other