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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 08/07/2015

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 282776672
• Report Number: 1220246-2021-04168
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867057791
• UDI-Public: 00888867057791
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: USP II HUMERAL HEAD 46/18
• Device Catalogue Number: AR-9146-18P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other