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)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 03/21/2018

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 device remains in patient.The root cause of the event could not be determined from the information available and without device evaluation.

Event 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)
• 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: 8483510
• MDR Text Key: 140948707
• Report Number: 1220246-2019-01000
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867234215
• UDI-Public: 00888867234215
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2017
• 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