MAUDE Adverse Event Report: ARTHREX, INC.; PROSTHESIS, SHOULDER, CEMENTED

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Discomfort (2330)

Event Date 10/26/2023

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

On 11/27/2023, a clindex notification was received indicating that a severe complication occurred that resulted in a revision surgery on (b)(6) 2023 for hardware removal.On (b)(6) 2023, the patient complained of continued weakness and pain when playing table tennis.A ct scan was performed on (b)(6) 2023 and noted avulsion of the subscapularis.Due to the pain and dissatisfaction with function, on (b)(6) 2023, the patient consented to a conversation surgery to a reverse tsa.The conversion surgery to reverse tsa occurred on (b)(6) 2023, and the patient had the first post-operation office visit on 11/8/2023.The original procedure was an eclipse performed on (b)(6) 2023.The patient declined to re-enroll in the shoulder arthroplasty registry and was withdrawn from the study.

• Brand Name: UNK
• Type of Device: PROSTHESIS, SHOULDER, 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: emily shafer ; 8009337001
• MDR Report Key: 18384354
• MDR Text Key: 331294394
• Report Number: 1220246-2023-09588
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/22/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: No
• 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