MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2019
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 patient underwent a tsa procedure on (b)(6) 2018.9 months post-op, on (b)(6) 2019, the patient was seen by their surgeon for a follow-up visit where an x-ray was taken to determine progress.The x-ray showed that the baseplate and glenosphere were dislocated.The patient stated that no trauma had occurred.A copy of the x-ray is unable to be obtained.A revision surgery took place on (b)(6) 2019 and the following devices were all explanted: ar-9145-30 / lot: 170156313, ar-9145-36 / lot: 170139313, ar-9504m / lot: 140119609, ar-9503m-06 / lot: 160010109, ar-9120-01 / lot: 170145515, and ar-9165-20 / lot: 150008108.The surgeon switched to an rtsa and implanted the following: ar-9502-39arca / lot: 261519 and ar-9550-19rca / lot: 10031668.
Additional Manufacturer Narrative
Complaint confirmed.Evaluation on the returned device revealed, the humeral insert/liner returned is notably worn at one end of the od.Since no x-rays were provided after multiple attempts, the cause for this event is undetermined.
Event or Problem Description
It was reported that the patient underwent a tsa procedure on (b)(6) 2018.9 months post-op, on (b)(6) 2019, the patient was seen by their surgeon for a follow-up visit where an x-ray was taken to determine progress.The x-ray showed that the baseplate and glenosphere were dislocated.The patient stated that no trauma had occurred.A copy of the x-ray is unable to be obtained.A revision surgery took place on (b)(6) 2019 and the following devices were all explanted: ar-9145-30 / lot: 170156313, ar-9145-36 / lot: 170139313, ar-9504m / lot: 140119609, ar-9503m-06 / lot: 160010109, ar-9120-01 / lot: 170145515, and ar-9165-20 / lot: 150008108.The surgeon switched to an rtsa and implanted the following: ar-9502-39arca / lot: 261519 and ar-9550-19rca / lot: 10031668.Additional information provided 3/29/2019: the ar-9145-30 screw broke upon removal of hardware.Tip was retrieved.

• Brand Name: HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8440395
• Report Number: 1220246-2019-00975
• Device Sequence Number: 1633590
• Product Code: PHX
• UDI-Device Identifier: 00888867061279
• UDI-Public: 00888867061279
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 03/08/2021
• Device Model Number: HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
• Device Catalogue Number: AR-9503M-06
• Device Lot Number: 160010109
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 08/16/2019
• 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