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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. MOVATION KNEE MOVATION TIBIAL INSERT, SIZE 6, 9MM VE

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ENCORE MEDICAL L.P. MOVATION KNEE MOVATION TIBIAL INSERT, SIZE 6, 9MM VE Back to Search Results
Catalog Number 292-09-706
Device Problem Unstable (1667)
Patient Problem Fall (1848)
Event Date 05/01/2017
Event Type  Injury  
Event Description
Revision surgery - due to the patient falling causing instability.
 
Manufacturer Narrative
The reason for this revision surgery was instability. The previous surgery and the revision detailed in this investigation occurred over 9 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 the hospital and not made available to djo surgical for examination. A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event. The device was within its expiration date at the time of use during the previous surgery. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The root cause of this complaint was a revision surgery due to an instability. The agent clearly mentioned that patient fell down caused instability of the joint and it seems that event might occurred due to trauma. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
 
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Brand NameMOVATION KNEE
Type of DeviceMOVATION TIBIAL INSERT, SIZE 6, 9MM VE
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 Key6599749
MDR Text Key76235153
Report Number1644408-2017-00390
Device Sequence Number1
Product Code OIY
UDI-Device Identifier0888912112413
UDI-Public(01)0888912112413
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/02/2021
Device Catalogue Number292-09-706
Device Lot Number316N1025
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2016
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: 05/30/2017 Patient Sequence Number: 1
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