MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. 3DKNEE; INSERT, 3D EX SZ 10LT 13MM

Catalog Number 391-13-710

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 05/27/2015

Event Type  Injury  

Event Description

Revision surgery - due to a possible infection, hematoma.

Manufacturer Narrative

The reason for this revision surgery was reported as an infection.The previous surgery and the revision detailed in this investigation occurred 16 days 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 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.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.Due to the short time between the original surgery and the revision, it is possible that the infection was acquired in the hospital (nosocomial).It is also possible that the patient was not compliant with post surgical instructions.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: 3DKNEE
• Type of Device: INSERT, 3D EX SZ 10LT 13MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 4815595
• MDR Text Key: 5833897
• Report Number: 1644408-2015-00328
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2016
• Device Catalogue Number: 391-13-710
• Device Lot Number: 59602247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR