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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 12LT 9MM

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ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 12LT 9MM Back to Search Results
Model Number 391-09-712
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2020
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as wash out and poly exchange. The previous surgery and the surgery detailed in this event occurred 2 months and 1 week 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 records (dhr) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements and showed no non-conforming material reports (ncmr) associated with the main contributor component listed in the complaint. The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery. Customer complaint history of the reported devices 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 wash out and poly exchange. There were no findings during this evaluation that indicate the reported devices were 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 such as poor bone density, patient bone deterioration, inadequate soft tissue support and patient activities or trauma. There are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery: due to wash out and exchange.
 
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Brand Name3D KNEE
Type of DeviceINSERT, 3D EX SZ 12LT 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
teffany hutto
9800 metric blvd
austin, tx 78758-5445, 
MDR Report Key9700545
MDR Text Key178960430
Report Number1644408-2020-00054
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912119009
UDI-Public(01)00888912119009
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 08/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number391-09-712
Device Catalogue Number391-09-712
Device Lot Number59603227A
Was Device Available for Evaluation? No
Date Manufacturer Received01/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2018
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: 02/12/2020 Patient Sequence Number: 1
Treatment
233-01-112 LOT 897A1093
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