MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 42 (+2 RIGHT); SHOULDR PROSTH HEMI- HUM UNCEM

Model Number UNIVERS REVERS SUTURE CUP, 42 (+2 RIGHT)

Device Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 09/19/2023

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

It was reported that after an initial surgery on (b)(6) 2023 the patient developed a severe infection which affected the patient for 6 months.A revision surgery was performed on (b)(6) 2023 to remove the involved implants.No further information received.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-9502f-42rcpc univers revers suture cup, 42 (+2 right) serial/batch number (b)(6) was received for investigation.A bullet nose screw was attached to the cup.Visual evaluation of the suture cup noted no issues with the returned device, only signs of wear; evaluation of the bullet nose screw found damaged in the hex head and thread, causing geometry loss.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.A cause for the reported failure may be a patient-specific event.Per dfu-0189-9 at revision 0.C.Contraindications.3.Foreign body sensitivity.Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation.D.Adverse effects.1.Infections, both deep and superficial.2.Foreign body reactions.7.Allergies and other reactions to device materials.

• Brand Name: UNIVERS REVERS SUTURE CUP, 42 (+2 RIGHT)
• 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: emily shafer ; 8009337001
• MDR Report Key: 17977007
• MDR Text Key: 326171675
• Report Number: 1220246-2023-08285
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867234277
• UDI-Public: 00888867234277
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K161782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

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 SUTURE CUP, 42 (+2 RIGHT)
• Device Catalogue Number: AR-9502F-42RCPC
• Device Lot Number: 21.03309
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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