MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 9999

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 12/22/2022

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation.

Event Description

As reported by the equinoxe shoulder study, the 53 year old female patient had an initial right tsa on (b)(6) 2022.The patient presented on (b)(6) 2022 with an allergy to copper.Subject has been seeing an allergist who dx her with an allergy to the copper in protheisis.The case report form indicates that this event is definitely related to device and to procedure.Outcome is continuing.Referral to allergist.Patient currently receives monthly shots or infusions to control symptoms.This helps.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18230443
• MDR Text Key: 329316512
• Report Number: 1038671-2023-02879
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• 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
• Treatment: UNK.
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American