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

Model Number UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL)

Device Problems Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 08/25/2020

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 on (b)(6) 2019 a patient had a reverse shoulder procedure.On (b)(6) 2020 the patient underwent a revision surgery.The patient had an autograft to the glenoid on her initial surgery and it did not appear to have healed.The sales representative who was present during the revision reports that the surgeon had mentioned in surgery that he believed that the locking mechanism on the baseplate may not have been functioning appropriately (the screw was not locked in).During the original procedure the following arthrex devices had been implanted: ar-9564-2436-lat, glenosphere, lot 18.00689.Ar-9503s-03, humeral insert, lot 18.00870.Ar-9502f-36cpc, univers revers suture cup, lot 170141708.Ar-9561-25p, modular central post, lot 5368.Ar-9560-24-2, modular baseplate, lot 5408.Ar-9562-36nl, peripheral screw non-locking, lot 2018001207.Ar-9563-36, peripheral screw locking, lot 2018001490.Ar-9563-40, peripheral screw locking, lot 2018001491.Ar-9501-12p, univers revers humeral stem size 12, lot 170125705.During the revision surgery all off the above listed original implants were explanted, except for the ar-9501-12p, univers revers humeral stem size 12, which was left in the patient.Explanted devices will be returned for evaluation.The surgeon completed the revision by doing a hemi arthroplasty and implanting the following arthrex products: ar-9502-36arca, revers ca adapter assembly, lot 18.01305.Ar-9544-17rca, revers ca humeral head, lot 10071302.Ar-9502f-36cpc, univers revers suture cup, lot 19.00846.The original and revision procedures were performed by the same surgeon at the same facility.

Manufacturer Narrative

Complaint not confirmed, no abnormality was observed on the device that may have contributed tot he event.

• Brand Name: UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL)
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10540379
• MDR Text Key: 207199802
• Report Number: 1220246-2020-02161
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867234192
• UDI-Public: 00888867234192
• Combination Product (y/n): N
• PMA/PMN Number: K161782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL)
• Device Catalogue Number: AR-9502F-36CPC
• Device Lot Number: 170141708
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other