MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; BASEPLATE, STEMMED, NON POROUS TIBIAL COCR SIZE6R

Model Number	324-01-106
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/27/2019
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 - patient had a bad fall and loosened the tibia.Surgeon felt it needed to a stem to secure it.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as loosening from a fall.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.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.A review of the device history records (dhr) was not conducted since the item or lot number was not provided or determined during the complaint evaluation.This complaint will be closed with the item and lot numbers unknown.Should additional information become available at a later date, the complaint will be updated customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to loosening from a fall.No other information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION KNEE
• Common Device Name: BASEPLATE, STEMMED, NON POROUS TIBIAL COCR SIZE6R
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9226113
• Report Number: 1644408-2019-01035
• Device Sequence Number: 460056
• Product Code: JWH
• UDI-Device Identifier: 00888912115186
• UDI-Public: (01)00888912115186
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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: 324-01-106
• Device Catalogue Number: 324-01-106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/21/2019
• 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: 385-09-506 LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 80 YR