MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION PRIMARY KNEE; INSERT, STD., PRIMARY, SIZE4 13MM CM

Catalog Number	385-13-504
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient presenting with pain.The surgeon felt it was due to poly wear (9 1/2 years post operation).The surgeon replaced the poly and decided to go with an ultra congruent option.
Additional Manufacturer Narrative
The reason for this revision surgery was knee pain.The previous surgery and the revision detailed in this investigation occurred over 9 ½ years apart.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 has not been made available to (b)(4) for examination.A review of the implant device history records (dhr) shows that the reported components 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 pain.The device was within the 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 knee pain.There are multiple factors that may contribute to the event that are outside the control of (b)(4) are patient activities, trauma, and patient non-compliance with medical instructions.The complaint does state that the event occurred over 9 ½ years post-operative and it seems that the poly insert might get eroded during this period of usage.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 PRIMARY KNEE
• Common Device Name: INSERT, STD., PRIMARY, SIZE4 13MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6322175
• Report Number: 1644408-2017-00090
• Device Sequence Number: 635096
• Product Code: JWH
• UDI-Device Identifier: 00888912117920
• UDI-Public: (01)00888912117920
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K000590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2017

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: Health Professional
• Device Expiration Date: 05/31/2012
• Device Catalogue Number: 385-13-504
• Device Lot Number: 53866193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 04/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 79 YR