MAUDE Adverse Event Report: ARTHREX, INC. USP II HUMERAL HEAD 46/18; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	USP II HUMERAL HEAD 46/18
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/07/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, it was reported by a sale representative via the phone that ar-9100-10s, ar-9146-18p and ar-9105-03 were explanted (b)(6) 2021 due to pain and rotator cuff failure confirmed by imaging.These devices were implanted on (b)(6) 2015 @ (b)(6) hospital.The case was completed using a competitors reverse total shoulder system.
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.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: USP II HUMERAL HEAD 46/18
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13087676
• Report Number: 1220246-2021-04168
• Device Sequence Number: 5926567
• Product Code: KWS
• UDI-Device Identifier: 00888867057791
• UDI-Public: 00888867057791
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/27/2021

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: USP II HUMERAL HEAD 46/18
• Device Catalogue Number: AR-9146-18P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown