MAUDE Adverse Event Report: ARTHREX, INC. USP II HUMERAL HEAD 46/20; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	USP II HUMERAL HEAD 46/20
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/01/2017
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 device was reported to have been discarded.The 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 shoulder arthroplasty procedure on (b)(6) 2017 where the following devices were implanted: ar-9100-10s lot: 10055062; ar-9106-01 lot: 1027261611 and ar-9146-20p lot: 160051618.On (b)(6) 2017, the patient underwent a revision tsa/glenoid revision and humeral head size reduction for an unknown reason and the following devices were explanted: ar-9106-01 lot: 1027261611 and ar-9146-20p lot: 160051618.These were replaced with: ar-9105-01 lot: 113601629 and ar-9144-19p lot: 160047318.

• Brand Name: USP II HUMERAL HEAD 46/20
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8209297
• Report Number: 1220246-2019-00829
• Device Sequence Number: 2027414
• Product Code: KWS
• UDI-Device Identifier: 00888867057807
• UDI-Public: 00888867057807
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

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: 07/31/2021
• Device Model Number: USP II HUMERAL HEAD 46/20
• Device Catalogue Number: AR-9146-20P
• Device Lot Number: 160051618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/02/2019
• 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