MAUDE Adverse Event Report: ARTHREX, INC. USP II HUMERAL HEAD 52/20; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number USP II HUMERAL HEAD 52/20

Device Problems Material Fragmentation (1261); Output Problem (3005)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 06/26/2019

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that the patient underwent a tsa procedure on (b)(6) 2019 where an arthrex ball and socket (pns unknown, pending operative report) were implanted into the patient¿s right shoulder.During the patient¿s follow up appointment, the patient complained of pain in his right shoulder and an x-ray was taken.According to the surgeon, there was nothing showing on the x-ray that was unusual.The surgeon suggested the pain was due to internal sutures in the patient¿s bicep but no further medical treatment was performed.The patient opted to see a different surgeon for the pain and in (b)(6) 2021 (exact date unknown, pending operative report), a laparoscopic procedure was performed for an internal visual.Once inside the joint, the surgeon found that the socket had exploded.He broke down the fragments and removed the fragments and cement from the tsa procedure arthroscopically¿no devices were implanted during this procedure.To date, the patient is still experiencing pain in the right shoulder as it is now ball on bone and also has a decrease in rom.The patient has seen a third surgeon who has suggested an rtsa, however, no procedure has been scheduled.Additional information provided 11/1/2021: operative reports have been provided and have been attached for both, the original tsa procedure performed on (b)(6) 2019 and the laparoscopic procedure performed on (b)(6) 2021.Requested the scrub sheet from the tsa procedure as pns were not documented on these reports.

• Brand Name: USP II HUMERAL HEAD 52/20
• 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: 13054443
• MDR Text Key: 284647960
• Report Number: 1220246-2021-04138
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867057883
• UDI-Public: 00888867057883
• 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: 12/21/2021

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 Expiration Date: 11/30/2023
• Device Model Number: USP II HUMERAL HEAD 52/20
• Device Catalogue Number: AR-9152-20P
• Device Lot Number: 10264713
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 12/21/2021
• Date Device Manufactured: 12/19/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other