MAUDE Adverse Event Report: EXACTECH, INC. SMALL EXTENDED CAGE GLENOID PLATE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-35-06

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2024

Event Type  Injury  

Event Description

As reported, the implant was opened and loaded with bone graft by the surgical tech before impaction.During impaction the implant would not fully seat and was pulled out to reassess.Upon loading the implant back on the inserter it was noticed by the tech that the cage had warped.The surgeon then decided to waste the implant and put in a new one.The new baseplate was impacted with no issues.This event is not associated with a revision of exactech implants.The patient was last known to be in stable condition following the event.

Manufacturer Narrative

Section h10: (h3) pending evaluation.

• Brand Name: SMALL EXTENDED CAGE GLENOID PLATE
• 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 court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19177879
• MDR Text Key: 341000678
• Report Number: 1038671-2024-00971
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862534903
• UDI-Public: 10885862534903
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• 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: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-35-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2019
• 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: 55 YR
• Patient Sex: Female