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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 8LT 9MM

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ENCORE MEDICAL L.P. 3D KNEE; INSERT, 3D EX SZ 8LT 9MM Back to Search Results
Model Number 391-09-708
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Scar Tissue (2060); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/22/2021
Event Type  Injury  
Event Description
Revision surgery - patient had flexion contracture.Removed insert and excised scar tissue and inserted new implant.
 
Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
 
Manufacturer Narrative
The reason for this revision surgery was reported as flexion contracture.The previous surgery and the surgery detailed in this event occurred 6 years and 11 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 devices were 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 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 flexion contracture.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.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 Name
3D KNEE
Type of Device
INSERT, 3D EX SZ 8LT 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
kiersten soderman
9800 metric blvd.
austin, TX 78758-5445
MDR Report Key13046934
MDR Text Key283938392
Report Number1644408-2021-01484
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912118989
UDI-Public(01)00888912118989
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 Physician
Type of Report Initial,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2018
Device Model Number391-09-708
Device Catalogue Number391-09-708
Device Lot Number59603729
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/23/2021
Initial Date FDA Received12/20/2021
Supplement Dates Manufacturer Received02/01/2022
Supplement Dates FDA Received02/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient SexMale
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