MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/16/2020
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.
Event or Problem Description
It was reported through the surgical outcome system that a issue possibly related to an arthrex product took place.Upon further investigation the following was discovered: a patient had undergone a reverse total shoulder arthroplasty 3/20/2019.It was diagnosed via x-ray and ct scan (b)(6) 2020 that the patient was experiencing loosening of the implant glenoid side.A revision of glenoid and humeral components with allograft surgery was performed (b)(6) 2020 during which time the following original arthrex implants were explanted: arthrex univers revers mgs peripheral screw nl 4.5x24 mm; lot #170182004; catalog # ar-9562-24nl.Arthrex univers revers mgs peripheral screw 4.5x32 mm; lot #2018001455; catalog # ar-9562-32nl; qty 2.Arthrex central screw modular 30 mm; lot #5652; catalog # ar-9561-30s.Arthrex glenosphere 39 +4 lat/24; lot #18.00656; catalog # ar-9564-2439-lat.Arthrex cup univers revs suture 39mm ntrl +2 left; lot #170074105; catalog # ar-9502f-39lcpc.Arthrex baseplate 24 m modular; lot #5362; catalog # ar-9560-24.After removal of the above devices the surgeon performed a conversion to hemiarthroplasty with glenoid bone graft.Additional information 11/16/2020: when the explanted products were returned for evaluation the original humeral insert m/39 +6 to fit in 39 cup, ar-9503m-06 (lot 18.00568) was also returned.It was not included in the original list of explanted products provided.
Additional Manufacturer Narrative
Complaint not confirmed, despite the severe wear concentrate on the edges, there is no indication the device loosened or may have contributed to the loosening of the glenoid implants.The cause of the wear is undetermined.

• Brand Name: HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10958007
• Report Number: 1220246-2020-02389
• Device Sequence Number: 3150049
• Product Code: PHX
• UDI-Device Identifier: 00888867061279
• UDI-Public: 00888867061279
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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: 07/31/2023
• Device Model Number: HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
• Device Catalogue Number: AR-9503M-06
• Device Lot Number: 18.00568
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other