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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 8RT 11MM

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ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 8RT 11MM Back to Search Results
Model Number 392-11-708
Device Problem Unstable (1667)
Patient Problem Failure of Implant (1924)
Event Date 10/22/2018
Event Type  Injury  
Event Description
Revision surgery - due to the patient developing instability. The surgeon put in a thicker poly.
 
Manufacturer Narrative
The reason for this revision surgery was due to instability. The previous surgery and the surgery detailed in this investigation occurred 1. 1 year apart. 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 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 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, when released for use, met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) 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 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 instability. There were no findings during this investigation that indicate that the reported device was 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 Name3D KNEE
Type of DeviceINSERT, 3D EX SZ 8RT 11MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key8091280
MDR Text Key127947287
Report Number1644408-2018-01010
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912120555
UDI-Public(01)00888912120555
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 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2019
Device Model Number392-11-708
Device Catalogue Number392-11-708
Device Lot Number59605197
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/20/2018 Patient Sequence Number: 1
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