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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT STEP WEDGE SZ4 5MM; MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY
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DEPUY ORTHOPAEDICS INC US MBT STEP WEDGE SZ4 5MM; MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY Back to Search Results
Model Number 1294-56-135
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Joint Laxity (4526)
Date of Event 11/19/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (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's knee was revised due to the tibia mid flexion instability and knee pain.The tibia, the two 5mm augments and the polyethylene were explanted and revised to help the issue.The component was not loose at all.The poly had no wear.Doi: unknown.Dor: (b)(6) 2020; left knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
MBT STEP WEDGE SZ4 5MM
Common Device Name
MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10968658
Report Number1818910-2020-26472
Device Sequence Number4282808
Product Code NJL
UDI-Device Identifier10603295026747
UDI-Public10603295026747
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/19/2020
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 Model Number1294-56-135
Device Catalogue Number129456135
Device Lot Number629580
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/19/2020
Supplement Date Received by Manufacturer01/08/2021
Initial Report FDA Received Date12/08/2020
Supplement Report FDA Received Date01/11/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
MBT REVISION CEM TIB TRAY SZ 4; MBT STEP WEDGE SZ4 5MM; PFC SIGMARP STB TB IN 4 12.5; UNKNOWN BONE CEMENT; MBT REVISION CEM TIB TRAY SZ 4; MBT STEP WEDGE SZ4 5MM; PFC SIGMARP STB TB IN 4 12.5; UNKNOWN BONE CEMENT
Outcome Attributed to Adverse Event Required Intervention;
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