MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SPACER 39+6MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERS REVERS SPACER 39+6MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2021
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 the incorrect sized implants were mistakenly used during a primary modular glenoid system rtsa surgery.The size of the humeral cup (39) used was mismatched with a size 36 glenosphere.Following the surgery, the mistake was noticed by the agency.They promptly alerted the surgeon of the incorrect implanted product.The surgeon notified the patient of the error, and the patient decided to have the components changed out for the correct sizes.The revision surgery was performed on (b)(6) 2021 to change out the size of the humeral cup and glenosphere.A new spacer and poly were also added to make sure the components matched.The patient was revised with the following material; ar-9503m-06 (lot: 18.00559), ar-9505-06 (lot: 20.02214), ar-9564-2439-lat (lot: 18.00657).The following arthrex products were explanted during the revision surgery; ar-9564-2436-lat (lot: 20.1788), ar-9505-06 (lot: 19.04327), ar-9503-3639-6 (lot: 19.03606).

• Brand Name: UNIVERS REVERS SPACER 39+6MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11801915
• Report Number: 1220246-2021-03061
• Device Sequence Number: 14382973
• Product Code: PHX
• UDI-Device Identifier: 00888867061422
• UDI-Public: 00888867061422
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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 SPACER 39+6MM
• Device Catalogue Number: AR-9505-06
• Device Lot Number: 19.04327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other