MAUDE Adverse Event Report: ENCORE MEDICAL L.P. IMPACTOR HEAD; DJO EMPOWR KNEETM, FEMORAL IMPACTOR HEAD

Model Number 800-05-025

Device Problem Device Handling Problem (3265)

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

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - during impacting of the femoral implant, the impactor tip disassociated from the metal base.

Manufacturer Narrative

The reason for this instrument failure was reported as disassociation.The possible time in service for baseplate is 5.2 years from manufactured date.Initial or prolonged hospitalization was required.The healthcare professional indicated this event occurred during surgery, near the patient.The device was not returned to manufacturer and made available at djo surgical for examination.A review of 800-05-025 device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) associated with the production of this instrument.Complaint database review showed 85 previous complaints, there were indications that this instrument has a design or material deficiency.Those are 85 broke/cracked/damaged.The root cause of this complaint is impactor tip disassociated from the metal base.There are no indications that this instrument has a material nonconformance.This issue does not create patient risk; therefore, no containment of inventory is required.The event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the instrument was not returned, it was lost / discarded on site.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: IMPACTOR HEAD
• Type of Device: DJO EMPOWR KNEETM, FEMORAL IMPACTOR HEAD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 15455925
• MDR Text Key: 300310768
• Report Number: 1644408-2022-01251
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 00888912408707
• UDI-Public: (01)00888912408707
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 800-05-025
• Device Catalogue Number: 800-05-025
• Device Lot Number: 245945L01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Male