MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - CENTRAL SCREW 20MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERSAL GLENOID - CENTRAL SCREW 20MM
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	12/05/2019
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 that a patient was originally operated on using the arthrex reverse shoulder on (b)(6) 2018.The patient originally had a small baseplate, 36 +4 glenosphere, size 8 stem, plus 6 spacer, 20 central screw, 2- 30mm peripheral screws and a plus 3 poly insert implanted.In (b)(6) 2019, the patient came to the surgeon's office complaining of pain and lack of motion.The decided to revise the patient.The revision procedure took place on (b)(6) 2019.The rep reported during the revision procedure, it was clearly obvious that the baseplate and screws had pulled out of the face of the glenoid.The surgeon removed the poly, spacer, baseplate, screws and glenosphere, and implanted an augmented exacttech glenoid implant and glenosphere.Once that was completed, the surgeon implanted a plus 12 arthrex spacer and a plus 3 poly liner onto the existing size 8 stem and 36 cup.The implants went in without any problem and the surgeon was very pleased with the post operative results.The surgeon chose to keep the implants that were extracted and expects the patient to do well.Additional information received on 01/06/2020: the rep reported they do not have access to the part or lot numbers of arthrex product from the primary procedure.However, the rep has all of the explanted arthrex product in their possession and are available to return for evaluation.The original procedure type was a primary reverse shoulder replacement.The primary and revision procedure were performed by the same surgeon at the same facility.The rep reported they were not made aware of when the patients symptoms first began or how the patient was treated for their symptoms.There are no available pictures or copies of x-rays.The bone quality was soft.A request has been sent to the rep for part and lot numbers of explanted arthrex parts.Additional information received on 01/15/2020: the rep provided the implant sheet from the primary (b)(6) 2018 procedure.The following arthrex parts were used during the primary procedure: ar-9120-01 / lot: 170131615 / qty.: 1, ar-9165-20 / lot: 150019408 / qty.: 1, ar-9145-30 / lot: 18.00582 / qty.: 2, ar-9504s-04 / lot: 170101514 / qty.: 1, ar-9501-08p / lot: 170063403 / qty.: 1, ar-9507s / lot: 10189586 / qty.: 1, ar-9502f-36cpc / lot: 170030306 / qty.: 1, ar-9555-06 / lot: 160116810 / qty.: 1, ar-9503s-03 / lot: 170091611 / qty.1.The following arthrex parts were explanted during the (b)(6) 2019 revision procedure and have been returned to arthrex: ar-9555-06 / lot: 160116810 / qty.: 1, ar-9503s-03 / lot: 170091611 / qty.1, ar-9504s-04 / lot: 170101514 / qty.: 1, ar-9120-01 / lot: 170131615 / qty.: 1, ar-9165-20 / lot: 150019408 / qty.: 1, ar-9145-30 / lot: 18.00582 / qty.: 2.
Additional Manufacturer Narrative
Complaint not confirmed, no abnormality that may have contributed to the event was observed on the device.A likely cause of the event is poor bone quality.

• Brand Name: UNIVERSAL GLENOID - CENTRAL SCREW 20MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9659039
• Report Number: 1220246-2020-01626
• Device Sequence Number: 2783957
• Product Code: PHX
• UDI-Device Identifier: 00888867057937
• UDI-Public: 00888867057937
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: No Information
• Device Expiration Date: 04/30/2020
• Device Model Number: UNIVERSAL GLENOID - CENTRAL SCREW 20MM
• Device Catalogue Number: AR-9165-20
• Device Lot Number: 150019408
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other