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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION CEM TIB TRAY S2.5; MBT TIBIAL TRAY : KNEE TIBIAL TRAY
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DEPUY ORTHOPAEDICS INC US MBT REVISION CEM TIB TRAY S2.5; MBT TIBIAL TRAY : KNEE TIBIAL TRAY Back to Search Results
Model Number 1294-35-125
Medical Device Problem Codes Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 10/26/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(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
Clinical notification received for revision of right total knee to address instability and tibial implant migration/loosening.Date of implantation: (b)(6) 2013, date of revision: (b)(6) 2020, (right knee).Treatment: revision of the tibial construct and insert.
 
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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
MBT REVISION CEM TIB TRAY S2.5
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 Key10928289
Report Number1818910-2020-25809
Device Sequence Number14523691
Product Code NJL
UDI-Device Identifier10603295025955
UDI-Public10603295025955
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
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) 11/13/2020
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? Yes
Operator of Device Health Professional
Device Model Number1294-35-125
Device Catalogue Number129435125
Device Lot NumberHH9502
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/13/2020
Supplement Date Received by Manufacturer01/07/2021
Initial Report FDA Received Date12/01/2020
Supplement Report FDA Received Date01/08/2021
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 TRAY SLEEVE POR M/L 37MM; PFC*SIGMA C/R NPOR FE RT SZ2.5; PFC*SIGMA/RD/DOME PAT 3PEG,35; SIG RP AOX CRV INS SZ2.5 15; SMARTSET HV BONE CEMENT 40G; UNIVERSAL STEM 75X10MM FLUTED; MBT TRAY SLEEVE POR M/L 37MM; PFC*SIGMA C/R NPOR FE RT SZ2.5; PFC*SIGMA/RD/DOME PAT 3PEG,35; SIG RP AOX CRV INS SZ2.5 15; SMARTSET HV BONE CEMENT 40G; UNIVERSAL STEM 75X10MM FLUTED
Outcome Attributed to Adverse Event Required Intervention;
Patient Age80 YR
Patient Weight73
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