MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE TIBIAL DOWNSIZE; FK 6/3D DOWN 8 POROUS STEMMED, TIBIA, LT

Catalog Number	336-01-108
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the tibia base being loose and needing to be revised.
Additional Manufacturer Narrative
The reason for this revision surgery was the tibia base was loose.The previous surgery and the revision detailed in this investigation occurred over 1 year apart.There are no reported pre-existing patient health conditions.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 device history records showed no non-conforming material reports associated with the main contributor component listed in the complaint.The device was within it's respective expiration date at the time of use during the previous surgery.Customer complaint history of the reported device (s) 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 loosened tibia base.There were no findings during this investigation that indicate that the reported device (s) was the source or had a direct connection with the patient's tibia base loosening.Several factors may contribute to patient joint looseness that are outside the control of djo surgical are loose joints from degenerative tissues, improper implant selection, aging of the patient.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to a loosening 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.
Additional Manufacturer Narrative
The incorrected part was reported as the suspect medical device on the initial medical device report (mdr) and on the follow-up #1 mdr.

• Brand Name: 3D KNEE TIBIAL DOWNSIZE
• Common Device Name: FK 6/3D DOWN 8 POROUS STEMMED, TIBIA, LT
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6301727
• Report Number: 1644408-2017-00047
• Device Sequence Number: 10908427
• Product Code: JWH
• UDI-Device Identifier: 00888912111713
• UDI-Public: (01)00888912111713
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K020114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 03/28/2020
• Device Catalogue Number: 336-01-108
• Device Lot Number: 313B1014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 04/06/2017; 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 110-02-032,LOT 395A1034; 336-01-108,LOT 313B1014; 391-09-708,LOT 285G1913
• Outcome Attributed to Adverse Event: Required Intervention