MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS GLENO 39 + 4 LAT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERS REVERS GLENO 39 + 4 LAT
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/04/2019
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 requested/is expected but has not returned for evaluation.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 after having a primary reverse shoulder arthroplasty procedure on 30072843132019, the patient's glenosphere disassociated post-op.The following arthrex parts were implanted during the primary procedure: ar-95075 // lot: 10271054; ar-9165-20nl // lot: 10260410; ar-9210-02 // lot: 18.01648; ar-9145-36 // lot: 18.00922; ar-9145-30 // lot: 18.01719; ar-9504m-04 // lot: 18.00869; ar-9501-06p // lot: 18.01549; ar-9502f-39cpc // lot: 18.00489; ar-9503m-03c // lot: 18.00111.The rep stated it is unknown if the patient was experiencing any pain or discomfort.A revision procedure was performed on (b)(6) 2019.The rep stated copies of x-ray's are not available, nor were any pictures taken.The primary and revision procedure were performed by the same surgeon and took place at the same facility.The following arthrex parts were explanted during the revision procedure: ar-9504m-04 // lot: 18.00869; ar-9502f-39cpc // lot: 18.00489; ar-9503m-03c // lot: 18.00111.The following arthrex parts were implanted during the revision procedure: ar-9504m-04 // lot: 18.01612; ar-9502f-39cpc // lot: 18.01655; ar-9505-06 // lot: 18.00982; ar-9503m-03c // lot: 18.01758/ additional information received on 07/18/2019: the rep stated the x-ray taken post-op lead the surgeon to perform the revision procedure.The explanted glenosphere is returning for evaluation.All other implants were discarded.
Additional Manufacturer Narrative
Complaint was not confirmed.Dimensional analysis of returned device confirms device meets specifications and critical mating features (morse taper) are within tolerance.No significant damage noted to device.As the baseplate was not returned for evaluation the condition of the mating surface is unknown.Based on the device evaluation, the cause of the event is undetermined.A most likely cause(s) of this type of event includes non-compliance to the post-op protocol or post-op trauma to the surgical site.Per device directions for use, until bone healing is complete, fixation given with this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.

• Brand Name: UNIVERS REVERS GLENO 39 + 4 LAT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8863837
• Report Number: 1220246-2019-01231
• Device Sequence Number: 2754580
• Product Code: PHX
• UDI-Device Identifier: 00888867061378
• UDI-Public: 00888867061378
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 10/31/2023
• Device Model Number: UNIVERS REVERS GLENO 39 + 4 LAT
• Device Catalogue Number: AR-9504M-04
• Device Lot Number: 18.00869
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/15/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1