MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE; FEMUR, POROUS COATED, 3D, SIZE5, LT

Model Number 236-01-105

Device Problem Failure to Align (2522)

Patient Problem Joint Dislocation (2374)

Event Date 05/09/2017

Event Type  Injury  

Event Description

Revision surgery - due to improper alignment in the patient.(mal alignment).

Manufacturer Narrative

The reason for this revision surgery was mal alignment.The previous surgery and the revision detailed in this investigation occurred over 7 months apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.The device was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to mal alignment.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.There are multiple factors that may contribute to the event that are outside the control of djo surgical are degenerative bone, excessive weight, unbalanced joint, incorrect implant selection or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3DKNEE
• Type of Device: FEMUR, POROUS COATED, 3D, SIZE5, LT
• 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: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445
• MDR Report Key: 6621512
• MDR Text Key: 76963944
• Report Number: 1644408-2017-00427
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00888912111676
• UDI-Public: (01)00888912111676
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2021
• Device Model Number: 236-01-105
• Device Catalogue Number: 236-01-105
• Device Lot Number: 944A1039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2015
• 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
• Treatment: 391-09-705,LOT 282G1903
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR