MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS STEM, SIZE 10, CAP COATED; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS REVERS STEM, SIZE 10, CAP COATED
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
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 requested/is expected but has not returned for evaluation.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 univers revers surgery the cup cannot be attached to the shaft.Due to this issue the surgeon had to change the surgical technique and used ar-9501-09cpc because there was no second ar-9501-10cpc inside the loaner set.The ar-9501-09cpc was cemented in.Update 29 nov 2018: the sales rep confirmed that initially it was planned to use a 10mm shaft for the univers revers surgery, but it should not be cemented.The channel for the 10mm shaft was already prepared, then it was noticed that the cup cannot be connected to the 10mm shaft.Because there was no second 10mm shaft in the set, an 11mm shaft was tried, but as it was too big, the 9mm shaft was used.But it was too small for the 10mm channel, the 9mm had to be cemented in.
Additional Manufacturer Narrative
The stem ar-9501-10cpc appears new with only one light dent near the threaded hole, no wear marks.Further examination of the thread shows damage on the first thread of the 155° hole.The cup ar-9502-39cpc also appears new, with minor marks on the top surface.The screw anodization is worn on the first 4 distal threads, and on a 1mm thick radial band between the thread and the screw head.The drive feature area is heavily scratched and dented.The first thread of the screw appears slightly damaged.Complaint confirmed.The most likely cause of why the cup was not able to be connected to the stem is that the screw was threaded in improperly, leading to damages to the first thread of the stem.

• Brand Name: UNIVERS REVERS STEM, SIZE 10, CAP COATED
• 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: 8155392
• Report Number: 1220246-2018-00796
• Device Sequence Number: 16725592
• Product Code: KWS
• UDI-Device Identifier: 00888867061057
• UDI-Public: 00888867061057
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2019

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: 05/31/2022
• Device Model Number: UNIVERS REVERS STEM, SIZE 10, CAP COATED
• Device Catalogue Number: AR-9501-10CPC
• Device Lot Number: 170011613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2018
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other