MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS II HUMERAL STEM 11MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS II HUMERAL STEM 11MM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/11/2019
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that on (b)(6) 2014 a total shoulder prosthesis from arthrex the universal-glenoid was implanted into the patient.During the year 2018 it was shown on x-ray pictures that the plastic inlay of the implant was worn out.Therefore a revision surgery was performed which confirmed that the plastic inlay was exfoliated, thinned and broken.No further information were provided.Update 18-may-2020: further information were provided that the devices are not available for evaluation.The initial results stated that the patient had the feeling that the shoulder is jumping and making noise.Which was confirmed during the clinical evaluation.The revision surgery was performed on (b)(6) 2019 due to a loosening shaft and inlay degradation on the right shoulder.The prosthesis was replaced with an inverse prosthesis and the shaft was also exchanged.

• Brand Name: UNIVERS II HUMERAL STEM 11MM
• 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: 10096434
• Report Number: 1220246-2020-01852
• Device Sequence Number: 19684534
• Product Code: KWS
• UDI-Device Identifier: 00888867057142
• UDI-Public: 00888867057142
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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 Expiration Date: 11/30/2015
• Device Model Number: UNIVERS II HUMERAL STEM 11MM
• Device Catalogue Number: AR-9100-11P
• Device Lot Number: 1049013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other