MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FOUNDATION KNEE; FOUNDATION P.S. TIBIAL INSERT SZ 8 13MM

Catalog Number 360-13-308

Device Problem Material Discolored (1170)

Patient Problem No Code Available (3191)

Event Date 09/15/2016

Event Type  Injury  

Event Description

Revision surgery - due to the post breaking off at the level of the poly.Also, it had pitted discoloration from oxidation.The surgeon did a poly swap.This patient has had multiple revisions, we were not able to find all of the previous information, only the last two surgeries.

Manufacturer Narrative

The reason for this revision surgery was the post broke at the surface of the poly.The complaint also states the insert had pitted discolored from oxidation.The complaint reports the patient has had a number of revisions over the years but a record can only be found for the original surgery and one revision surgery.This complaint addresses a part explanted from the first revision in 2003.The in-vivo length of service for the patient's implant was 13.1 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 (b)(4) for examination.A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions and specifications in effect at the time the part was manufactured were met.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed to be non-product related.The root cause for post for the posterior stabilized (ps) tibia beaking was not reported.The complaint also states the insert had pitted discolored from oxidation, however; without the part being available to (b)(4) for evaluation this condition cannot be confirmed.Other conditions, root cause, relating to this event could not be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION KNEE
• Type of Device: FOUNDATION P.S. TIBIAL INSERT SZ 8 13MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 6024479
• MDR Text Key: 57249281
• Report Number: 1644408-2016-00770
• Device Sequence Number: 1
• Product Code: JWH
• 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: 09/15/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2006
• Device Catalogue Number: 360-13-308
• Device Lot Number: 755781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2001
• 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: 76 YR