MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/08/2018
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 not returned for evaluation.Disposition of explanted device is unknown.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 a patient had undergone a total reverse shoulder procedure on (b)(6) 2018 during which the following arthrex devices were implanted: ar-9502f-36rcpc (lot 170027905); ar-9502f-36cpc (lot 170018606); ar-9501-06p (lot 170088903); ar-9503s-03 (170085610); ar-9504s-inf (lot 160071710); ar-9120-01 (lot 170115115); ar-9165-20 (lot 170056412); ar-9145-24 (lot 170101712).Patient also underwent a revision procedure on (b)(6) 2018 during which the ar-9503s-03 was explanted and an ar-9503s-06 (lot 170150113)was implanted.This report (case (b)(4)) is to document the revision surgery.Patient has recently been admitted to the hospital due to a shoulder infection which is being reported under the following complaint numbers: (b)(4).

• Brand Name: HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8483671
• Report Number: 1220246-2019-01008
• Device Sequence Number: 16511716
• Product Code: PHX
• UDI-Device Identifier: 00888867061293
• UDI-Public: 00888867061293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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: No Information
• Device Expiration Date: 09/30/2022
• Device Model Number: HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
• Device Catalogue Number: AR-9503S-03
• Device Lot Number: 170085610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/04/2019
• 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