MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SPACER 36+6MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number UNIVERS REVERS SPACER 36+6MM

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 12/05/2019

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 a patient was originally operated on using the arthrex reverse shoulder on (b)(6) 2018.The patient originally had a small baseplate, 36 +4 glenosphere, size 8 stem, plus 6 spacer, 20 central screw, 2- 30mm peripheral screws and a plus 3 poly insert implanted.In (b)(6) 2019, the patient came to the surgeon's office complaining of pain and lack of motion.They decided to revise the patient.The revision procedure took place on (b)(6) 2019.The rep reported during the revision procedure, it was clearly obvious that the baseplate and screws had pulled out of the face of the glenoid.The surgeon removed the poly, spacer, baseplate, screws and glenosphere, and implanted an augmented exacttech glenoid implant and glenosphere.Once that was completed, the surgeon implanted a plus 12 arthrex spacer and a plus 3 poly liner onto the existing size 8 stem and 36 cup.The implants went in without any problem and the surgeon was very pleased with the post operative results.The surgeon chose to keep the implants that were extracted and expects the patient to do well.Additional information received on 01/06/2020: the rep reported they do not have access to the part or lot numbers of arthrex product from the primary procedure.However, the rep has all of the explanted arthrex product in their possession and are available to return for evaluation.The original procedure type was a primary reverse shoulder replacement.The primary and revision procedure were performed by the same surgeon at the same facility.The rep reported they were not made aware of when the patients symptoms first began or how the patient was treated for their symptoms.There are no available pictures or copies of x-rays.The bone quality was soft.A request has been sent to the rep for part and lot numbers of explanted arthrex parts.Additional information received on 01/15/2020: the rep provided the implant sheet from the primary (b)(6) 2018 procedure.The following arthrex parts were used during the primary procedure; ar-9120-01 // lot: 170131615 // qty.: 1.Ar-9165-20 // lot: 150019408 // qty.: 1.Ar-9145-30 // lot: 18.00582 // qty.: 2.Ar-9504s-04 // lot: 170101514 // qty.: 1.Ar-9501-08p // lot: 170063403 // qty.: 1.Ar-9507s // lot: 10189586 // qty.: 1.Ar-9502f-36cpc // lot: 170030306 // qty.: 1.Ar-9555-06 // lot: 160116810 // qty.: 1.Ar-9503s-03 // lot: 170091611 // qty.1.The following arthrex parts were explanted during the (b)(6) 2019 revision procedure and have been returned to arthrex; ar-9555-06 // lot: 160116810 // qty.: 1.Ar-9503s-03 // lot: 170091611 // qty.1.Ar-9504s-04 // lot: 170101514 // qty.: 1.Ar-9120-01 // lot: 170131615 // qty.: 1.Ar-9165-20 // lot: 150019408 // qty.: 1.Ar-9145-30 // lot: 18.00582 // qty.: 2.

Manufacturer Narrative

Complaint not confirmed.There were no allegations against the device, no abnormality was observed.

• Brand Name: UNIVERS REVERS SPACER 36+6MM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9659050
• MDR Text Key: 191073695
• Report Number: 1220246-2020-01629
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867062474
• UDI-Public: 00888867062474
• Combination Product (y/n): N
• PMA/PMN Number: K142863
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: UNIVERS REVERS SPACER 36+6MM
• Device Catalogue Number: AR-9555-06
• Device Lot Number: 160116810
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other