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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 4, 9MM VE, PRODUCT CODE:

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ENCORE MEDICAL L.P. MOVATION KNEE MOVATION TIBIAL INSERT, SIZE 4, 9MM VE, PRODUCT CODE: Back to Search Results
Model Number 292-09-704
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2016
Event Type  Injury  
Manufacturer Narrative
Corrected data: mfr report # was incorrect. Correct mfr report # 1644408-2016-00447. The reason for this revision surgery was the patient needed a thicker insert. The in-vivo length of service for the patient's implant was 1. 4 years. There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery. 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 device history records (dhrs) revealed no discrepancies or issues with the manufacturing history of this part. All parts were found to meet design and manufacturing specifications. No non-conforming material reports (ncmr's) were associated with this part. The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review. This event is deemed to be non-product related. The root cause for event was not reported. The surgeon reported no issues associated with the explanted product. The scope of this investigation is limited without having the parts available to djo surgical for evaluation. Other conditions, root cause, relating to this event could not be determined with confidence. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - due to the patient needing a thicker insert.
 
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Brand NameMOVATION KNEE
Type of DeviceMOVATION TIBIAL INSERT, SIZE 4, 9MM VE, PRODUCT CODE:
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 Key9203079
MDR Text Key162810179
Report Number1644408-2016-00447
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912112390
UDI-Public(01)00888912112390
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 Non-Healthcare Professional
Type of Report Initial
Report Date 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2019
Device Model Number292-09-704
Device Catalogue Number292-09-704
Device Lot Number304N1005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2014
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: 10/17/2019 Patient Sequence Number: 1
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