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

Model Number SHOULDER - IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2024

Event Type  Injury  

Event Description

As reported, the surgeon removed an exactech humeral head, replicator plate and caged glenoid of the 70 y/o male patient due to failed tsa.Patient was revised to a exactech/arthrex hybrid reverse shoulder, there was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays received.The devices are not available for evaluation.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: SHOULDER - IMPLANT
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18762247
• MDR Text Key: 336026674
• Report Number: 1038671-2024-00301
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SHOULDER - IMPLANT
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 97