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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 6LT 11MM

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ENCORE MEDICAL, L.P. 3DKNEE INSERT, 3D EX SZ 6LT 11MM Back to Search Results
Model Number 391-11-706
Device Problems Loose or Intermittent Connection (1371); Unstable (1667)
Patient Problem No Code Available (3191)
Event Date 05/17/2017
Event Type  Injury  
Event Description
Revision surgery: due to the patient having presented with ligament laxity and instability. The surgeon decided a thicker poly would resolve the ligament issue.
 
Manufacturer Narrative
The reason for this revision surgery was the patient presented with ligament laxity and instability. The in-vivo length of patient service for the implant was 2. 3 years. The healthcare professional indicated there was a significant adverse event to the patient. There was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The device has not been made available to djo surgical for examination. 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 ligament laxity and instability. 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.
 
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Brand Name3DKNEE
Type of DeviceINSERT, 3D EX SZ 6LT 11MM
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 5445
Manufacturer Contact
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
MDR Report Key6645587
MDR Text Key77701786
Report Number1644408-2017-00452
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912119221
UDI-Public(01)00888912119221
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 07/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2019
Device Model Number391-11-706
Device Catalogue Number391-11-706
Device Lot Number59605252
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 Received06/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2014
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: 06/15/2017 Patient Sequence Number: 1
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