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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 8RT 11MM

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ENCORE MEDICAL L.P. 3DKNEE INSERT, 3D EX SZ 8RT 11MM Back to Search Results
Model Number 392-11-708
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Adhesion(s) (1695); Loss of Range of Motion (2032)
Event Date 05/01/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was the patient had flexion issues requiring a poly insert exchange. The in-vivo length of patient service for the implant was 11. 5 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 insert is set to be returned but has not been returned. On arrival it will be evaluated. A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part. All critical dimensions, design criteria and specifications in effect at the time the part was manufactured were met. The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review. This event is deemed as non-product related. The root cause for this event was the patient had flexion issues requiring a poly insert exchange. The scope of this investigation is limited without having the explanted parts available to djo surgical for evaluation. Other conditions relating to this event could not be determined with confidence. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - due to the patient developing flexion contracture after the primary total knee arthroplasty (tka) and was unable to bend their knee enough; requiring surgical lysis of adhesions today. The surgeon replaced the 11mm poly insert with a thinner 9mm insert to help the patient regain the motion he had difficulty with, so he can regain his flexion. The poly exchange went smoothly.
 
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Brand Name3DKNEE
Type of DeviceINSERT, 3D EX SZ 8RT 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
mrs. hutto
9800 metric blvd.
austin, TX 78758-5445
MDR Report Key6599831
MDR Text Key113682626
Report Number1644408-2017-00414
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912120555
UDI-Public(01)00888912120555
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 08/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2017
Device Model Number392-11-708
Device Catalogue Number392-11-708
Device Lot Number59602704
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 Received07/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2012
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: 05/30/2017 Patient Sequence Number: 1
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