MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS STEM, SIZE 10, CAP COATED; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS REVERS STEM, SIZE 10, CAP COATED
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint confirmed.One unpackaged ar-9501-10cpc univers revers stem - cap coated - size 10 serial/batch number 21.03415 was received for investigation.Visual evaluation noted that the stem threaded holes were damaged.Dents were also observed on the surface of the device.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 STEM, SIZE 10, CAP COATED
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 17976969
• Report Number: 1220246-2023-08283
• Device Sequence Number: 19724830
• Product Code: PHX
• UDI-Device Identifier: 00888867061057
• UDI-Public: 00888867061057
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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
• Operator of Device: Health Professional
• Device Model Number: UNIVERS REVERS STEM, SIZE 10, CAP COATED
• Device Catalogue Number: AR-9501-10CPC
• Device Lot Number: 21.03415
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown