MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE; FEMUR, NONPOROUS, 3D, SIZE12, RT

Model Number 392-09-612

Device Problems Unstable (1667); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2009

Event Type  Injury  

Manufacturer Narrative

This mdr is being reported after learning about a potential device related event following a review of clinical study records.The internal standard operating procedure for complaint reporting has been updated to reflect a requirement for all clinical study events to be handled in the same manner as all product complaints.

Event Description

Reported incident - due to a failed right side total knee arthroplasty (tka), device instability.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was due to a failed right total knee arthroplasty (tka) device instability.The previous surgery and the revision detailed in this investigation occurred 4.3 years 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 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.This analysis is limited in scope as the devices associated with this event was not returned to djo surgical - (b)(6) for examination.If additional information regarding the event is submitted at a future date, this analysis will be re-evaluated.A review of the device history records (dhr), shows that the reported devices used in the primary surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the devices that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of use during the primary surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are in need of review.The root cause of this event is due to a failed right total knee arthroplasty (tka) device instability.There were no findings during this analysis that indicate that the reported devices were defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3D KNEE
• Type of Device: FEMUR, NONPOROUS, 3D, SIZE12, RT
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7397364
• MDR Text Key: 104381065
• Report Number: 1644408-2018-00290
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00888912120210
• UDI-Public: (01)00888912120210
• Combination Product (y/n): N
• PMA/PMN Number: K032905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 392-09-612
• Device Catalogue Number: 233-02-112
• Device Lot Number: 53956092
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 130-03-035, LOT 53859269; 130-03-035, LOT 53859269; 233-02-112, LOT 53956092; 324-01-110, LOT 53971963; 324-01-110, LOT 53971963; 392-09-612, LOT 458952; 130-03-035, LOT 53859269; 233-02-112, LOT 53956092; 324-01-110, LOT 53971963
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 123