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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT CEM KEEL TIB TRAY SZ6; MBT TIBIAL TRAY : KNEE TIBIAL TRAY
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DEPUY ORTHOPAEDICS INC US MBT CEM KEEL TIB TRAY SZ6; MBT TIBIAL TRAY : KNEE TIBIAL TRAY Back to Search Results
Catalog Number 129433160
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 11/29/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
The patient was revised due to fall, causing the tibia to subside on the medial side.A bigger insert was placed.Doi: (b)(6), 2011; dor: (b)(6) 2018; left knee.
 
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Brand Name
MBT CEM KEEL TIB TRAY SZ6
Common Device Name
MBT TIBIAL TRAY : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8196732
Report Number1818910-2018-79118
Device Sequence Number10825977
Product Code NJL
UDI-Device Identifier10603295025818
UDI-Public10603295025818
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/29/2018
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
Operator of Device Health Professional
Device Catalogue Number129433160
Device Lot Number2319874
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/29/2018
Initial Report FDA Received Date12/26/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age55 YR
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