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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HIGHLY CROSS-LINKED KNEE INSERT, 3D EX SZ 8LT 11MM

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ENCORE MEDICAL L.P. HIGHLY CROSS-LINKED KNEE INSERT, 3D EX SZ 8LT 11MM Back to Search Results
Model Number 391-11-708
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 10/31/2019
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as unknown at this time. The previous surgery and the surgery detailed in this event occurred 7. 7 years apart. The healthcare professional indicated there was no significant adverse event. There was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended and without incident. A review of the device history record (dhr) show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements. There were no nonconforming material reports (ncmr) associated with the product that may have contributed to the reported event. The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery. Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review. The root cause of this complaint was a revision surgery due to unknown reasons. There were no findings during this evaluation that indicate the reported devices were defective. 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 event. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. There are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery due to unknown reason.
 
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Brand NameHIGHLY CROSS-LINKED KNEE
Type of DeviceINSERT, 3D EX SZ 8LT 11MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445 TX 78758 5445
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445 TX 78758 5445
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, tx 78758-5445, TX 78758-5445
MDR Report Key9396132
MDR Text Key168773065
Report Number1644408-2019-01170
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091956
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/28/2016
Device Model Number391-11-708
Device Catalogue Number391-11-708
Device Lot Number59601875
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/02/2019 Patient Sequence Number: 1
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