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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 7LT 13MM

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ENCORE MEDICAL L.P. 3DKNEE INSERT, 3D EX SZ 7LT 13MM Back to Search Results
Model Number 391-13-707
Device Problem Unstable (1667)
Patient Problem No Information (3190)
Event Date 02/17/2014
Event Type  Injury  
Manufacturer Narrative
This mdr is being reported after learning about a potential device related event following a review of clinical study records. The internal standard operating procedure for complaint reporting has been updated to reflect a requirement for all clinical study events to be handled in the same manner as all product complaints.
 
Event Description
Revision surgery - due to the patient having left knee instability.
 
Manufacturer Narrative
The reason for this reported incident was due to left side - left knee instability. This event did not involve the devices being removed. This analysis is limited in scope as the devices associated with this event remain in the patient, therefore will not be returned to djo surgical - austin for examination. If additional information regarding the event is submitted at a future date, this analysis will be re-evaluated. A review of the device history records (dhr) shows that the reported devices used in the primary surgery, when released for use, met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) associated with the devices that may have contributed to the reported event. The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of use during the primary surgery. Customer complaint history of the reported devices showed no present trends or on-going issues that are in need of review. The root cause of this event is due to left side - left knee instability. There were no findings during this analysis that indicate that the reported devices were defective. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. Inventory containment is not required as 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 7LT 13MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key7397369
MDR Text Key104380704
Report Number1644408-2018-00304
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912119511
UDI-Public(01)00888912119511
Combination Product (y/n)N
PMA/PMN Number
K091956
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2016
Device Model Number391-13-707
Device Catalogue Number391-13-707
Device Lot Number59601524
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/04/2018 Patient Sequence Number: 1
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