MAUDE Adverse Event Report: EXACTECH, INC. SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 03/25/2024

Event Type  Injury  

Event Description

It was reported that a 73 yo male patient, initial right shoulder implanted on an unknown date, underwent a revision procedure on (b)(6) 2024.The surgeon revised a failed exactech stemless anatomic shoulder and removed all implants.The patient was revised to a competitor¿s devices.There were no device breakages or surgical delays during the procedure.X-rays were provided.The patient was last known to be in stable condition following the event.The explanted devices are not available to return for analysis.Photos were provided.No further information.No other patient information/medical history reported.

Manufacturer Narrative

H3: pending investigation.

• Brand Name: SHOULDER COMPONENTS
• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19154954
• MDR Text Key: 340795401
• Report Number: 1038671-2024-00931
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 120