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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/04/2022

Event Type  Injury  

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

On (b)(6) 2022, it was reported by a sales representative via phone that a patient had a right shoulder rtsa on (b)(6) 2019.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.Additional information received on (b)(6) 2022: the original procedure occurred on (b)(6) 2019 and patient underwent revision surgery on (b)(6) 2020.Both procedures were performed at the same facility and by the same surgeon.On (b)(6) 2019, an ar-9501-05p humeral stem, an ar-9502f-36cpc suture cup, an ar-9503-3633-3 humeral inserter, (2) ar-9560-24 baseplate, from different lot numbers, an ar-9561-20s central screw, an ar-9561-25s central screw, (3) ar-9563-16 peripheral locking screws, one being from a different lot number, and and ar-9564-2433 glenosphere were implanted.Sales representative cannot confirm which devices were explanted during revision surgery on 7/17/2020.However, during revision surgery on 7/17/2020, an ar-9503-3633-3c humeral inserter, an ar-9560-24 baseplate, an ar-9561-35s central screw, and ar-9563-16 peripheral locking screw, ar-9563-20 peripheral locking screw, ar-9563-24 peripheral locking screw, an ar-9563-32 peripheral locking screw, and an ar-9564-2433-lat glenosphere were implanted.

• 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: 14573276
• MDR Text Key: 293284414
• Report Number: 1220246-2022-05007
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• 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
• Device Lot Number: 19.02069
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• Date Device Manufactured: 09/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other