MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. 3DKNEE; FEMUR, NONPOROUS, 3D, SIZE8, RT

Catalog Number	233-02-108
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 - the patient had gone to the dentist to have 2 infected teeth removed and did not get put on any antibiotics.This ensured an infection in the right knee, therefore all components were removed except for the patella.
Additional Manufacturer Narrative
The reason for this revision surgery was an infection.The previous surgery and the revision detailed in this investigation occurred 1.6 years apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was not completed as intended, the patient is to return for another surgery at a later date.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 (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 was reported as, "the patient had gone to the dentist to have 2 infected teeth removed and did not get put on any antibiotics.This ensured an infection in the right knee".Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3DKNEE
• Common Device Name: FEMUR, NONPOROUS, 3D, SIZE8, RT
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 6115670
• Report Number: 1644408-2016-00878
• Device Sequence Number: 734943
• Product Code: MBH
• UDI-Device Identifier: 00888912111256
• UDI-Public: (01)00888912111256
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K032905
• 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): 12/20/2016

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: 08/28/2019
• Device Catalogue Number: 233-02-108
• Device Lot Number: 914A224
• 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: 12/20/2016
• 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: 333-02-108,LOT 278B1082; 392-09-608,LOT 59602301
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 109