MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	01/16/2020
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 a revision reverse total shoulder took place on (b)(6) 2020.The rep reported the revision procedure was due to a displaced greater tuberosity fracture that needed to be retrieved.Prior to the revision procedure the patient was experiencing pain and a lack of range of motion.The patient had a follow-up visit with their surgeon.X-rays taken during the follow up visit revealed a displaced greater tuberosity fracture.The primary and revision procedure were performed by the same surgeon and took place at the same facility.The rep reported at this time the date of the primary surgery, and full list of arthrex product implanted during the primary procedure is currently unknown.Additional information has been requested.The following arthrex parts were explanted during the revision: ar-9503s-03 / lot: 19.00085 / qty.: 1, ar-9564-2436-lat / lot: 18.01595 / qty.: 1, ar-9502f-36cpc / lot: 18.01518 / qty.: 1, ar-9501-05p / lot: 18.00881 / qty.: 1.The following arthrex parts were implanted during the revision: ar-9564-2436 / lot: 19.00917 / qty.: 1.The rep stated the humeral components implanted during the revision procedure were from a different manufacturer.Additional information received on 01/20/2020: the rep reported the date of the primary procedure was (b)(6) 2019.The original procedure was a reverse total shoulder.After the primary procedure the patient started experiencing pain and loss of function.The rep reported the exact time frame of when the patients symptoms started is unknown.De-identified copies of post-op x-rays are not available.See attached pictures of explanted product.The rep reported the hospital will retain the explanted implants for their own testing.However, the explanted product could potentially be returned to arthrex once the testing process is completed.The following arthrex products were implanted during the primary procedure: ar-9501-05p / lot: 18.00881, ar-9502f-36cpc / lot: 18.01518, ar-9503s-03 / lot: 19.00085, ar-9560-24-2 / lot: 6090, ar-9561-20s / lot: 5684, ar-9564-2436-lat / lot: 18.01595, ar-9563-16 / lot: 2019001454, ar-9562-28nl / lot: 2018005021.

• Brand Name: HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9659053
• Report Number: 1220246-2020-01631
• Device Sequence Number: 3172045
• Product Code: PHX
• UDI-Device Identifier: 00888867061293
• UDI-Public: 00888867061293
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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: 04/30/2024
• Device Model Number: HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
• Device Catalogue Number: AR-9503S-03
• Device Lot Number: 19.00085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other