MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 6MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, 6MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/16/2018
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 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 or Problem 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: UNIVERS APEX HUMERAL STEM, 6MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8155060
• Report Number: 1220246-2018-00790
• Device Sequence Number: 18895257
• Product Code: KWS
• UDI-Device Identifier: 00888867134416
• UDI-Public: 00888867134416
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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 Model Number: UNIVERS APEX HUMERAL STEM, 6MM
• Device Catalogue Number: AR-9100-06S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/12/2018
• 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