MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 39 (+2 RIGHT); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number UNIVERS REVERS SUTURE CUP, 39 (+2 RIGHT)

Device Problems Break (1069); Fracture (1260); Malposition of Device (2616)

Patient Problem Fall (1848)

Event Date 02/03/2021

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 root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that the surgeon implanted a univers revers apex and modular glenoid system (mgs) construct during a primary right reverse total shoulder arthroplasty case.The patient increased activity per the standard protocol.At 19 months post-op, the patient fell and had a periprosthetic fracture.At the time of revision for the periprosthetic fracture, the patient had a stable modular glenoid system implant construct.The revers apex humeral implants were removed.The wright medical revive revision humeral stem was implanted due to the periprosthetic fracture.At 26 months post-op from the initial index reverse total shoulder procedure, the patient presented with no function.X-rays showed a failed modular glenoid system implant construct.The inferior screw was broken and the implants had shifted.On (b)(6) 2021, a second revision was performed to remove the modular glenoid system implants.The glenoid implants were removed in one piece with no bone on growth.A wright medical reverse glenoid construct was implanted in place.No infection.Additional information received on 4/27/2021: the rep reported the primary revers total shoulder surgery was done on (b)(6) 2019.The rep cannot confirm the date or any additional details pertaining to the first revision surgery.The second revision was performed on (b)(6) 2021.All items from the original procedure have been explanted and no arthrex implants were implanted during either revision.The rep does not have access to explanted implants or x-rays.

• Brand Name: UNIVERS REVERS SUTURE CUP, 39 (+2 RIGHT)
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 11798532
• MDR Text Key: 249755867
• Report Number: 1220246-2021-03033
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867234246
• UDI-Public: 00888867234246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNIVERS REVERS SUTURE CUP, 39 (+2 RIGHT)
• Device Catalogue Number: AR-9502F-39RCPC
• Device Lot Number: 170112005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other