MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FOUNDATION KNEE; INSERT, STD., PRIMARY, SIZE4 9MM CM

Catalog Number	385-09-504
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient having an infection; the surgeon exchanged the original insert.
Additional Manufacturer Narrative
The reason for this revision surgery was an infection.The previous surgery and the revision detailed in this investigation occurred over 10 years apart.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 possible infection or inhibited the patient's immune system.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 (b)(4) for examination.A review of the implant device history records (dhrs) and product complaint report (pcr) database records show 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 an infection.The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.There were no findings during this investigation that indicate that the reported device was the root cause or had a direct connection with the patient's infection.There are multiple factors that may contribute to an infection that are outside of the control of (b)(4).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 9MM CM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 5886575
• Report Number: 1644408-2016-00564
• Device Sequence Number: 1387427
• Product Code: JWH
• UDI-Device Identifier: 00888912117722
• UDI-Public: (01)00888912117722
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K923277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2008
• Device Catalogue Number: 385-09-504
• Device Lot Number: 888261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2016
• Supplement Report FDA Received Date: 09/14/2016
• 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: 80 YR