MAUDE Adverse Event Report: EXACTECH, INC. REPLICATOR PLATE

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

The case report form indicates these events are definitely not related to devices and procedure.This event report was received through clinical data collection activities.Pending evaluation.

Event Description

Index surgery: (b)(6) 2015.Revision due to aseptic loosening.

Manufacturer Narrative

The case report form indicates these events are definitely not related to devices and procedure.This event report was received through clinical data collection activities.Engineering evaluation noted that the revision reported was likely the result of aseptic loosening of the glenoid component, humeral component, or both.However, this cannot be confirmed as the devices were not available for evaluation and no further information was provided.

Event Description

Index sugery: (b)(6) 2015.Revision due to aseptic glenoid loosening.

• Brand Name: REPLICATOR PLATE
• Type of Device: REPLICATOR PLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 7693996
• MDR Text Key: 114172790
• Report Number: 1038671-2018-00599
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR
• Patient Weight: 78