MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL); SHOULDR PROSTH HEMI- HUM UNCEM

Model Number UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL)

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 05/18/2023

Event Type  Injury  

Event Description

On 5/19/2023, it was reported by a sales representative via email that an ar-9501-06p humeral stem, an ar-9502f-36cpc suture cup, an ar-9503s-03 humeral insert, an ar-9564-2436-lat glenosphere, an ar-9560-24 baseplate, an ar-9561-35s central screw, (2) ar-9563-28 peripheral screw, and (2) ar-9563-20 peripheral screw, were explanted during a revision shoulder arthroplasty surgery on (b)(6) 2023.On (b)(6) 2022, the patient underwent original surgery.Then on (b)(6) 2023, the patient started to experience pain.Radiographs appeared to show some radiolucent lines around the baseplate.The patient did not report any falls or notable events.The infection type has not been confirmed.During the revision surgery, an ar-9150-21 ca humeral head and an ar-9100-05p monoblock stem were implanted as functional antibiotic spacers.Both procedures were performed by the same surgeon but at different facilities.

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: 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: 17111608
• MDR Text Key: 317039656
• Report Number: 1220246-2023-06895
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• 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, 36 (NEUTRAL)
• Device Catalogue Number: AR-9502F-36CPC
• Device Lot Number: 21.02483
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2023
• Date Device Manufactured: 11/01/2021
• 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