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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 4RT 11MM

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ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 4RT 11MM Back to Search Results
Model Number 392-11-704
Device Problem Unstable (1667)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 08/04/2020
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as due to pain, unstable, loss of motion. The previous surgery and the surgery detailed in this event occurred 4. 3 years apart. 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 hospital and not made available to djo surgical for examination. A review of the device history record (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements. There were no non-conforming material reports (ncmr) associated with the products 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 the previous surgery. Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review. The root cause of this complaint was a revision surgery due to pain, unstable, loss of motion. There were no findings during this evaluation that indicate the reported device was defective. No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event. There are multiple factors that may contribute to an event that are outside the control of djo surgical. There are no indications of a product or process issue affecting implant safety or effectiveness. Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
Event Description
Revision surgery - due to pain, unstable, loss of motion.
 
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Brand Name3D KNEE
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 Key10476875
MDR Text Key205193508
Report Number1644408-2020-00751
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912120517
UDI-Public(01)00888912120517
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2016
Device Model Number392-11-704
Device Catalogue Number392-11-704
Device Lot Number59601737
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2011
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: 09/01/2020 Patient Sequence Number: 1
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