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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE INSERT, 3D EX SZ 4RT 11MM

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ENCORE MEDICAL L.P. 3DKNEE INSERT, 3D EX SZ 4RT 11MM Back to Search Results
Model Number 392-11-704
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Failure of Implant (1924); Arthralgia (2355)
Event Date 05/17/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was bilateral knee pain. The in-vivo length of patient service for the implant was 2 years and 10 months. There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery. There are no reported pre-existing patient health conditions. 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 djo surgical for examination. A review of the implant device history records (dhr) shows 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 the event. The device was within its expiration date at the time of use during the previous surgery. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The root cause of this complaint was a revision surgery due to the bilateral knee pain and loosening of femur on left side. There are multiple factors that may contribute to the event that are outside the control of djo surgical are degenerative tissues, patient activities, patient bone deterioration , excessive range-of-motion, excessive load or trauma. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness. The revision surgery was completed successfully.
 
Event Description
Revision surgery - due to bilateral knee pain. The femur on left side was loose. A poly insert exchange was done on the right knee; the surgeon went up a size. This complaint is reporting on the patient's right side surgery.
 
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Brand Name3DKNEE
Type of DeviceINSERT, 3D EX SZ 4RT 11MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd.
austin TX 78758 5445
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd.
austin TX 78758 5445
Manufacturer Contact
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
MDR Report Key6647753
MDR Text Key151871859
Report Number1644408-2017-00556
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
Type of Report Initial,Followup
Report Date 08/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2018
Device Model Number392-11-704
Device Catalogue Number392-11-704
Device Lot Number59603002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2013
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: 06/16/2017 Patient Sequence Number: 1
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