MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; INSERT, STD., PRIMARY, SIZE4 19MM CM

Model Number	385-19-504
Health Effect - Clinical Code	Rupture (2208)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to pcl (posterior cruciate ligament) rupture.
Additional Manufacturer Narrative
The reason for this revision surgery was due to a posterior cruciate l igament (pcl) rupture.The previous surgery and the surgery detailed in this investigation occurred 14.5 years apart.The healthcare professional indicated 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.The previous invoice did not contain the item and or lot numbers, therefore; a review of the device history records (dhr) could not be conducted.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 pcl rupture.There were no findings during this investigation that indicate that the reported device was defective.The surgeon performed this procedure to remedy the patient's condition.No 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 of 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: INSERT, STD., PRIMARY, SIZE4 19MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8655531
• Report Number: 1644408-2019-00483
• Device Sequence Number: 2600790
• Product Code: JWH
• UDI-Device Identifier: 00888912118057
• UDI-Public: (01)00888912118057
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• 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): 07/15/2019

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: 385-19-504
• Device Catalogue Number: 385-19-504
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 07/15/2019
• 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: Required Intervention
• Patient Age: 82 YR