MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); No Code Available (3191)
Date of Event	03/21/2018
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.The device remains in patient.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.The revision surgery is being reported under case (b)(4).Patient has recently been admitted to the hospital due to a shoulder infection.The infection is being reported under the following: (b)(4).

• Brand Name: UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8483510
• Report Number: 1220246-2019-01000
• Device Sequence Number: 1315156
• Product Code: HSD
• UDI-Device Identifier: 00888867234215
• UDI-Public: 00888867234215
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)
• Device Catalogue Number: AR-9502F-36RCPC
• Device Lot Number: 170027905
• 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