MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, PE WITH PEG, MEDIUM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number GLENOID, PE WITH PEG, MEDIUM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Laxity (4526)

Event Date 09/19/2022

Event Type  Injury  

Event Description

It was reported that a revision surgery was necessary due to an aseptic loosening of the glenoid.The shoulder prosthesis was changed to an inverse shoulder prosthesis.No further information received.

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.

• Brand Name: GLENOID, PE WITH PEG, MEDIUM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 15576298
• MDR Text Key: 301559526
• Report Number: 1220246-2022-05594
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867057326
• UDI-Public: 00888867057326
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K083435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: GLENOID, PE WITH PEG, MEDIUM
• Device Catalogue Number: AR-9105-02
• Device Lot Number: 1448011
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/20/2022
• Date Device Manufactured: 02/11/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other