MAUDE Adverse Event Report: ARTHREX, INC. USP II HUMERAL HEAD 44/19; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	USP II HUMERAL HEAD 44/19
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/04/2018
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 (captured on case (b)(4)) for an unknown reason and the following devices were explanted: ar-9106-01 lot: 1027261611 (medwatch 1220246-2019-00828) and ar-9146-20p lot: 160051618 (medwatch 1220246-2019-00829) and replaced with: ar-9105-01 lot: 113601629 and ar-9144-19p lot: 160047318.The patient then underwent a second revision tsa on (b)(6) 2018.Upon entering the joint space, the surgeon realized the head was barely associated to the trunion.Moreover, the trunion was disassociated from the stem as well and the superior version screw was backed all the way out.Essentially the stem fell apart into 4 pieces: the screw, the head, the stem, and the trunion.The following devices were explanted and replaced with a system from another manufacturer: ar-9100-10s lot: 10055062 (implanted during (b)(6) 2017 original procedure); ar-9105-01 lot: 113601629 (implanted during (b)(6) 2017 revision procedure) and ar-9144-19p lot: 160047318 (implanted during (b)(6) 2017 revision procedure).

• Brand Name: USP II HUMERAL HEAD 44/19
• 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: 8209559
• Report Number: 1220246-2019-00833
• Device Sequence Number: 19552938
• Product Code: KWS
• UDI-Device Identifier: 00888867057708
• UDI-Public: 00888867057708
• 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: 2018
• 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: 06/30/2021
• Device Model Number: USP II HUMERAL HEAD 44/19
• Device Catalogue Number: AR-9144-19P
• Device Lot Number: 160047318
• 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