MAUDE Adverse Event Report: ENCORE MEDICAL L. P. FOUNDATION KNEE SYSTEM; BASEPLATE, STEMMED, NON POROUS TIBIAL COCR SIZE4R

Model Number	324-01-104
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to patient is 15+ years post-op.Presented with tibia that had loosened and subsided.
Additional Manufacturer Narrative
Corrected data: see b5, d8 & g4.Manufacturer narrative: the reason for this revision surgery was reported as loosening.The previous surgery and the surgery detailed in this event occurred 16.7 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 devices were disposed of at hospital and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical for review.The revised items were not returned for examination and lot numbers were not provided.To adequately investigate this event, lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.The root cause of this complaint was reported as loosening.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Revision surgery - patient is 15+ years post-operation.Presented with tibia that had loosened and subsided.

• Brand Name: FOUNDATION KNEE SYSTEM
• Common Device Name: BASEPLATE, STEMMED, NON POROUS TIBIAL COCR SIZE4R
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 11659485
• Report Number: 1644408-2021-00278
• Device Sequence Number: 3097898
• Product Code: JWH
• UDI-Device Identifier: 00888912115179
• UDI-Public: (01)00888912115179
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K970031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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 Model Number: 324-01-104
• Device Catalogue Number: 324-01-104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 385-13-504, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR