MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SPACER 36+9MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number UNIVERS REVERS SPACER 36+9MM

Device Problems Break (1069); Corroded (1131); Unstable (1667); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2020

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.

Event Description

It was reported that the patient had undergone an initial revision surgery on (b)(6) 2018 during which the following devices were implanted: ar-9120-01 (lot 170115215), ar-9145-36 (lot 170037012), ar-9145-30 (lot 170057712), ar-9504s-04 (lot 170091414), ar-9555-09 (lot 2501367202), ar-9503s-03c (lot 2501374603), ar-9165-25 (lot 2501357504).The (b)(6) 2018 procedure was a revision of arthrex products because the patient had glenoid instability due to baseplate placement on the primary.It is unknown if the 2018 revision was ever reported to arthrex as no details from the original surgery are known to search/match part numbers.The implants put in on (b)(6) 2018 were done so in a compromised glenoid with poor bone quality.The peripheral screws broke and led to baseplate failure.The glenosphere remained engaged in the baseplate.There was significant corrosion of the humeral poly insert.The glenoid components failed nearly two years ago but the patient waited until (b)(6) 2020 to have a revision surgery.The sales representative reported that the surgeon attributed the failure to putting the baseplate on her original reverse procedure too superior on the face of the glenoid with significant superior tilt.Pictures were provided to arthrex.Explanted devices will not be returned for evaluation because the parts are being analyzed by the hospital for infection.

• Brand Name: UNIVERS REVERS SPACER 36+9MM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 10482829
• MDR Text Key: 205473830
• Report Number: 1220246-2020-02121
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867062481
• UDI-Public: 00888867062481
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: UNIVERS REVERS SPACER 36+9MM
• Device Catalogue Number: AR-9555-09
• Device Lot Number: 2501367202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other