MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS II HUMERAL STEM 12MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS II HUMERAL STEM 12MM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/06/2018
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 the device was explanted on (b)(6) 2018 due to an non-repairable rotator cuff repair.Additional information obtained (b)(6) 2018: the patient was participating in an eclipse tsa study program.The devices listed below were implanted on (b)(6) 2016.The surgeon reported that the rotator cuff was torn and appeared to be from trauma, but patient denied.The subject received a reverse device after the original devices were explanted.The patient subject was terminated from the study upon device removal.The devices were discarded prior to arthrex being notified as it was thought that the devices did not need to be returned as they did not feel it was a device malfunction.

• Brand Name: UNIVERS II HUMERAL STEM 12MM
• 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: 8054574
• Report Number: 1220246-2018-00729
• Device Sequence Number: 19228902
• Product Code: KWS
• UDI-Device Identifier: 00888867057166
• UDI-Public: 00888867057166
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2018

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: No Information
• Device Model Number: UNIVERS II HUMERAL STEM 12MM
• Device Catalogue Number: AR-9100-12P
• Device Lot Number: 2501301211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/09/2018
• 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