MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT L/42 +3 TO FIT IN 42 CUP; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL INSERT L/42 +3 TO FIT IN 42 CUP
Medical Device Problem Codes	Biocompatibility (2886); 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: h6 complaint confirmed.One unpackaged ar-9503l-03 humeral insert l/42+3, fit in 42 cup serial/batch number 20.01920, was received for investigation.Visual evaluation noted indentations/damage 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-0189-6 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.Allergies and other reactions to device materials.

• Brand Name: HUMERAL INSERT L/42 +3 TO FIT IN 42 CUP
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: 17959204
• Report Number: 1220246-2023-08247
• Device Sequence Number: 15214777
• Product Code: PHX
• UDI-Device Identifier: 00888867061217
• UDI-Public: 00888867061217
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: HUMERAL INSERT L/42 +3 TO FIT IN 42 CUP
• Device Catalogue Number: AR-9503L-03
• Device Lot Number: 20.01920
• 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: 09/25/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• 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