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

Model Number UNIVERS REVERS APEX STEM, SIZE 10

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Numbness (2415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2019

Event Type  Injury  

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 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
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: vik bajnath ; 8009337001
• MDR Report Key: 10763672
• MDR Text Key: 214147738
• Report Number: 1220246-2020-02284
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867250512
• UDI-Public: 00888867250512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other