MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE; INSERT, 3D EX SZ 10LT 9MM

Model Number	391-09-710
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the tibial loosening and significant poly compression.The patient had osteolysis from the poly through the screw holes.
Additional Manufacturer Narrative
The reason for this revision surgery was due to tibial loosening and significant poly compression.The previous surgery and the revision detailed in this investigation occurred over 6 years and 8 months apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was 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 tibial loosening and significant poly compression.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 such as: excessive loading, poor bone density, inadequate soft tissue support, degenerative tissue, patient bone deterioration, patient activities or trauma.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3DKNEE
• Common Device Name: INSERT, 3D EX SZ 10LT 9MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8175067
• Report Number: 1644408-2018-01157
• Device Sequence Number: 2025623
• Product Code: JWH
• UDI-Device Identifier: 00888912118996
• UDI-Public: (01)00888912118996
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K091956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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: 06/30/2016
• Device Model Number: 391-09-710
• Device Catalogue Number: 391-09-710
• Device Lot Number: 59601902
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/10/2019
• 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: 311-02-108, LOT A1000000; 311-02-108, LOT A1000000
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 59 YR