MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNI GLENOID-PERIPHERAL LOCK SCRW
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/19/2020
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 the patient had undergone an initial revision surgery on 1/24/18 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: UNI GLENOID-PERIPHERAL LOCK SCRW
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10482773
• Report Number: 1220246-2020-02119
• Device Sequence Number: 16448645
• Product Code: PHX
• UDI-Device Identifier: 00888867057722
• UDI-Public: 00888867057722
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• 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): 09/02/2020

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: 09/30/2022
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-30
• Device Lot Number: 170057712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/02/2020
• 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