MAUDE Adverse Event Report: EXACTECH, INC. SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.

Event Description

As reported, the patient had an initial left tsa on (b)(6) 2022.The baseplate screw broke and the patient was revised on an unknown date.The screw was removed and the baseplate was replaced.The patient had polycystic bone at the time of initial implantation.The surgeon believes the bone collapsed and led to micro motion, causing the screw to break.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information provided.

• Brand Name: SHOULDER COMPONENTS
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17148936
• MDR Text Key: 317446910
• Report Number: 1038671-2023-01390
• Device Sequence Number: 1
• Product Code: HSD
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• 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
• Distributor Facility Aware Date: 05/19/2023
• Date Manufacturer Received: 05/19/2023
• 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): Required Intervention
• Patient Sex: Female