MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, 5MM; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number UNIVERS REVERS HUMERAL STEM, 5MM

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Unspecified Infection (1930)

Event Date 03/02/2023

Event Type  Injury  

Event Description

On 3/22/2023, it was reported by a sales representative via email that a revision shoulder arthroplasty procedure took place on (b)(6) 2023 due to an infection.The surgeon removed an ar-9580-2420 univers revers modular glenoid system augmented baseplate, an ar-9582-20 modular post for augmented mgs baseplate, an ar-9562-32nl univers revers modular glenoid system, peripheral screw, non-locking 4.5 x 32 mm, an ar-9562-24nl univers revers modular glenoid system, peripheral screw, non-locking 4.5 x 24 mm, an ar-9563-20 univers revers modular glenoid system, peripheral screw, locking 5.5 x 20 mm, an ar-9563-16 univers revers modular glenoid system, peripheral screw, locking 5.5 x 16 mm, an ar-9564-2436-lat arthrex univers revers modular glenoid system glenosphere, an ar-9503s-06 arthrex univers revers humeral insert, an ar-9502f-36cpc arthrex univers revers suture cup, and an ar-9501-05p univers revers humeral stem.Additional information received on 3/23/2023: the original procedure occurred on (b)(6) 2021.About ten months later, the patient started to experience symptoms of infection.A culture was taken off the infected areas, but results are still pending.The same surgeon at the same facility performed both procedures.All the parts implanted during the original procedure on (b)(6) 2021 were explanted during the revision surgery on (b)(6) 2023.The patient is stable and was discharged from the hospital on (b)(6) 2023.

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 HUMERAL STEM, 5MM
• 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: 16762610
• MDR Text Key: 313512831
• Report Number: 1220246-2023-06555
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867247628
• UDI-Public: 00888867247628
• 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: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNIVERS REVERS HUMERAL STEM, 5MM
• Device Catalogue Number: AR-9501-05P
• Device Lot Number: 20.02978
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/18/2023
• 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