MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS GLENO 36 +4 LAT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERS REVERS GLENO 36 +4 LAT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/07/2019
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 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 that the prostheses failed about 2,5 month after surgery.Initial surgery was successfully completed on (b)(6) 2019 and patient was released to rehab.About 2.5 month after surgery, the glenosphere of the prostheses became luxated because patient was leaning on his arms.As a consequence of the luxation, the prostheses had to be changed in a revision surgery.Revision surgery was performed on (b)(6) 2019.No further information had been made available.Further questions asked.Update 17-oct-2019: patient is an elderly lady ((b)(6) years).No trauma reported.According to the hospital she was compliant to the post op guidelines.Xrays have been taken but not been made available by the hospital.
Additional Manufacturer Narrative
Complaint not confirmed.The device was returned free of damage and was found to meet dimensional specifications.A likely cause of dissociation is improper and/or incomplete mating of the taperlock feature due to interference from surrounding tissue.

• Brand Name: UNIVERS REVERS GLENO 36 +4 LAT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9255030
• Report Number: 1220246-2019-01382
• Device Sequence Number: 13966797
• Product Code: PHX
• UDI-Device Identifier: 00888867061408
• UDI-Public: 00888867061408
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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 Model Number: UNIVERS REVERS GLENO 36 +4 LAT
• Device Catalogue Number: AR-9504S-04
• Device Lot Number: 18.01384
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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