MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE; INSERT, 3D EX SZ 6RT 9MM

Model Number 392-09-706

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Abrasion (1689)

Event Date 04/24/2019

Event Type  Injury  

Event Description

Revision surgery - due to the implant having not normal marks after 6 months of use.The abrasion is not normal for 6 months.

Manufacturer Narrative

The reason for this revision surgery was reported as a worn tibial insert.The previous surgery and the surgery detailed in this event occurred 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 hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the tibial insert used in the previous surgery met design and manufacturing requirements when released for use.There were no non-conforming material reports (ncmr) associated with the implant that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.The root cause of this complaint was revision surgery due to a worn tibial insert is third body wear.There were no findings during this evaluation that indicate the reported device was defective.Possible sources of third body wear are cement or bone debris.The pitting and wear on the implant's articulating surface were likely caused by debris from the surgery.This caused some resistance in the movement between the implanted parts, which may explain the patient's pain, and swelling.No 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 the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3DKNEE
• Type of Device: INSERT, 3D EX SZ 6RT 9MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445 TX 78758 5445
• MDR Report Key: 8672699
• MDR Text Key: 147157804
• Report Number: 1644408-2019-00536
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912120265
• UDI-Public: (01)00888912120265
• Combination Product (y/n): N
• PMA/PMN Number: K091956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 392-09-706
• Device Catalogue Number: 392-09-706
• Device Lot Number: 328G1130
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 74