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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 5RT 9MM

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ENCORE MEDICAL L.P 3D KNEE INSERT, 3D EX SZ 5RT 9MM Back to Search Results
Model Number 392-09-705
Device Problem Unstable (1667)
Patient Problem Joint Laxity (4526)
Event Date 06/27/2022
Event Type  Injury  
Event Description
Revision surgery - due to instability.
 
Manufacturer Narrative
The reason for this revision surgery was reported as instability. The previous surgery and the surgery detailed in this event occurred 9 years and 9 months apart. Initial or prolonged hospitalization was required. 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 hospital and not made available to djo surgical for examination. A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements. There was a nonconformance associated with the main part # 392-09-705, insert, 3d ex sz 5rt 9mm which documents that out of 17 parts lot, 2 parts were rejected and scrapped in which 1 part was rejected due to scratches in the area b and other part was rejected due to inclusion in the area c. All other items in the lot were met with the design, fit and function requirements. 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 instability. 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 also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma. 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.
 
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Brand Name3D KNEE
Type of DeviceINSERT, 3D EX SZ 5RT 9MM
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
james mcmahon
9800 metric blvd
austin, tx 78758-5445 
MDR Report Key15001919
MDR Text Key295799441
Report Number1644408-2022-00893
Device Sequence Number1
Product Code OIY
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
Report Date 07/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2016
Device Model Number392-09-705
Device Catalogue Number392-09-705
Device Lot Number59601792
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2011
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: 07/13/2022 Patient Sequence Number: 1
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