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 Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2018

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 device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that during a right revision tsa to rtsa procedure, after the surgeon inserted the 33 glenosphere with the glenosphere inserter, ar-9624, the surgeon was removing the inserter and as it was unscrewed, he noticed that the tip had broken off.The tip of the inserter was lodged in the glenosphere.The surgeon decided to leave the sheared off tip in the glenosphere as it was tight in the baseplate and was not sitting proud.Additional information provided 11/19/2018: the original apex stem was implanted during a tsa procedure on (b)(6) 2016.Since then, the stem had drifted towards the lateral cortex, as well as a rotator cuff tear.All hardware was explanted.It was an apex stem, a 48/19 head, and a pegged glenoid component.Additional information provided 11/21/2018: the following three devices were explanted during the revision surgery: ar-9100-06s, ar-9148-19p, ar-9105-02.

• 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: 8155452
• MDR Text Key: 130079180
• Report Number: 1220246-2018-00792
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GLENOID, PE WITH PEG, MEDIUM
• Device Catalogue Number: AR-9105-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: No
• 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