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ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 4LT 11MM Back to Search Results
Model Number 391-11-704
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2020
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as instability. The previous surgery and the surgery detailed in this event occurred 2 years and 10 months 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) 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 report (ncmr) 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 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 contribute to the event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, degenerative bone disease, patient activities or trauma. There are no indications of a product or process issue affecting implant safety or effectiveness.
Event Description
Revision surgery - patient had suspected infection. Surgeon found no infection, but patient was unstable. Poly swap was done.
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Brand Name3D KNEE
Type of DeviceINSERT, 3D EX SZ 4LT 11MM
Manufacturer (Section D)
9800 metric blvd
austin, tx 78758-5445,
Manufacturer (Section G)
9800 metric blvd
austin, tx 78758-5445,
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, tx 78758-5445, 
MDR Report Key9938702
MDR Text Key187520747
Report Number1644408-2020-00288
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912119207
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/23/2021
Device Model Number391-11-704
Device Catalogue Number391-11-704
Device Lot Number290G1913
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2016
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: 04/08/2020 Patient Sequence Number: 1