MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FOUNDATION PRIMARY KNEE; INSERT, STD., PRIMARY, SIZE6 9MM CM

Catalog Number	385-09-506
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/26/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient walking barefoot down a hot paved road burning her feet, which allowed a massive infection.All components had to be removed.Temporary "space holders" are in place with antibiotics.
Additional Manufacturer Narrative
The reason for this revision surgery was a massive infection.The previous surgery and the revision detailed in this investigation occurred over 1.3 yrs.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 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 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.The root cause of this complaint is the patient burned her feet that contributed to the infection or inhibited the patient's immune system.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION PRIMARY KNEE
• Common Device Name: INSERT, STD., PRIMARY, SIZE6 9MM CM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 6115690
• Report Number: 1644408-2016-00904
• Device Sequence Number: 82232
• Product Code: JWH
• UDI-Device Identifier: 00888912117746
• UDI-Public: (01)00888912117746
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K923277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2016

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: No Information
• Device Expiration Date: 06/28/2019
• Device Catalogue Number: 385-09-506
• Device Lot Number: 484B1056
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2016
• Supplement Report FDA Received Date: 12/21/2016
• 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: 120-01-032,LOT 469A1075; 201-01-104,LOT 711A1114; 323-01-106,LOT 219B1141
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR