MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, 5MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number UNIVERS REVERS HUMERAL STEM, 5MM

Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2022

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2022, it was reported by a sales representative via phone that a patient had a right shoulder rtsa on (b)(6) 2019.Patient underwent a revision surgery due to chronic instability of the glenoid, which appeared to be worn out.However, sales representative could not confirm if any of the arthrex implanted devices had broken.

Manufacturer Narrative

The purpose of this follow-up submission is to update the device part number from unknown to the new part number.

• Brand Name: UNIVERS REVERS HUMERAL STEM, 5MM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 14468928
• MDR Text Key: 292471770
• Report Number: 1220246-2022-04941
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867247628
• UDI-Public: 00888867247628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNIVERS REVERS HUMERAL STEM, 5MM
• Device Catalogue Number: AR-9501-05P
• Device Lot Number: 19.00135
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other