MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; INSERT, STD., PRIMARY, SIZE8 11MM CM

Model Number	385-11-508
Health Effect - Clinical Code	Rupture (2208)
Date of Event	04/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - the patient had a foundation knee.The surgeon went in to fix the patient's ruptured extensor mechanism, that was not directly effected by a djo product.He decided to insert a thicker poly in the process.
Additional Manufacturer Narrative
The reason for this revision surgery was to fix a patient's ruptured extensor mechanism.The previous surgery and the revision detailed in this investigation occurred over 4 years and 10 months apart.There was no information submitted with this complaint about any patient activities, accidents or medical contraindications that may have contributed to the event.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.Initial or prolonged hospitalization was required.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported component 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 the event.The device was within its 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 to fix a patient's ruptured extensor mechanism.There are multiple factors that may contribute to the event that are outside the control of djo surgical are an unbalanced joint, inadequate soft tissue support, excessive load or patient activities.Agent has mentioned that the event was not due to the djo product and it seems that event may occurred due to trauma or patient non-compliance with medical instructions.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event 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 KNEE
• Common Device Name: INSERT, STD., PRIMARY, SIZE8 11MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6560324
• Report Number: 1644408-2017-00342
• Device Sequence Number: 19004582
• Product Code: JWH
• UDI-Device Identifier: 00888912117876
• UDI-Public: (01)00888912117876
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K923277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2017

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: 06/30/2016
• Device Model Number: 385-11-508
• Device Catalogue Number: 385-11-508
• Device Lot Number: 59601953
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 06/30/2017
• 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: Required Intervention
• Patient Age: 70 YR