MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS APEX STEM, SIZE 10; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERS REVERS APEX STEM, SIZE 10
Health Effect - Clinical Codes	Numbness (2415); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/01/2019
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 through the surgical outcome system that a patient may have had an issue as a result of surgery involving arthrex implants.Upon further investigation it was discovered that a patient had a (b)(6) 2019 reverse shoulder replacement procedure.After the nerve block had worn off, approximately 24 hours post surgery the patient was experiencing numbness in the surgical arm's palm, half of ring finger and the pinkie finger.The patient was diagnosed with ulnar nerve palsy and told it may take a year to resolve.Patient consulted with a neurologist, who said nothing could be done.The ulnar nerve was damaged.No second surgery has been performed.The following are the arthrex products that were implanted (b)(6) 2019: ar-9560 28-4 / lot: 6094.Ar-9561-25p / lot: 5685.Ar-9502f-39rcpc / lot: 19.00275.Ar-9501-105 / lot: 18.0037.Ar-9564-2839-lat / lot: 18.02027.Ar-9562-28nl / lot: 2018005880.Ar-9503m-06 / 19.00667.Ar-9563-28 / lot: 2019001687.Ar-9563-24 / lot: 19.02242.Ar-9562-28nl / lot: 2018005880.

• Brand Name: UNIVERS REVERS APEX STEM, SIZE 10
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10763672
• Report Number: 1220246-2020-02284
• Device Sequence Number: 17015610
• Product Code: PHX
• UDI-Device Identifier: 00888867250512
• UDI-Public: 00888867250512
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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: 08/31/2023
• Device Model Number: UNIVERS REVERS APEX STEM, SIZE 10
• Device Catalogue Number: AR-9501-10S
• Device Lot Number: 18.00337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 10/30/2020
• 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