MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION PS KNEE; INSERT, CONSTRAINED, P.S., SIZE4 11MM CM

Model Number 370-11-504

Device Problem Delamination (2904)

Patient Problem Pain (1994)

Event Date 10/11/2017

Event Type  Injury  

Event Description

Revision surgery - due to the patient being presented with pain, 12 years post surgery.The original insert had posterior lateral delamination.

Manufacturer Narrative

The reason for this revision surgery was the patient had pain.The in-vivo length of patient service for the implant was 12 years.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.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 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.This event is deemed to be non-product related.The root cause of this complaint was a revision surgery due to knee pain.There are multiple factors that may contribute to the event that are outside the control of djo surgical are patient activities, patient bone deterioration, prolonged usage, excessive loading 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 pain 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: FOUNDATION PS KNEE
• Type of Device: INSERT, CONSTRAINED, P.S., SIZE4 11MM CM
• 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: 7010360
• MDR Text Key: 91358243
• Report Number: 1644408-2017-00942
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00888912116619
• UDI-Public: (01)00888912116619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933539
• 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: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2008
• Device Model Number: 370-11-504
• Device Catalogue Number: 370-11-504
• Device Lot Number: 923331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2003
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 83 YR