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 Material Split, Cut or Torn (4008)

Patient Problem Fall (1848)

Event Date 03/17/2021

Event Type  Injury  

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 Description

It was reported a patient had a revision surgery.The original surgery date was (b)(6) 2019.The patient fell on (b)(6) 2020 and suffered from a rotator cuff tear.This was the purpose of the revision.The following parts were removed ar-9100-06s, ar-9146-18p and ar-9106-02.The total shoulder replacement was removed and replaced today.Male patient (b)(6) years of age.The revision case was completed and the patient is now fine to date.

• 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: 11627257
• MDR Text Key: 244192425
• Report Number: 1220246-2021-02837
• 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: 04/07/2021

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
• Device Operator: Health Professional
• Device Model Number: USP II HUMERAL HEAD 46/18
• Device Catalogue Number: AR-9146-18P
• Device Lot Number: 10173091
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other