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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT CEM TIBIAL TRAY SZ3; KNEE TIBIAL TRAY
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DEPUY ORTHOPAEDICS INC US MBT CEM TIBIAL TRAY SZ3; KNEE TIBIAL TRAY Back to Search Results
Catalog Number 129431130
Medical Device Problem Code Loose or Intermittent Connection (1371)
Health Effect - Clinical Code Fall (1848)
Date of Event 01/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional narrative: 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
Patient fell and tibial component came loose.Had to revise original surgery performed in may.No unexpected delays in surgery.
 
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .
 
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Brand Name
MBT CEM TIBIAL TRAY SZ3
Common Device Name
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7221094
Report Number1818910-2018-52094
Device Sequence Number14031933
Product Code NJL
UDI-Device Identifier10603295025603
UDI-Public10603295025603
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 01/10/2018
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 Number129431130
Device Lot Number8382444
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/10/2018
Supplement Date Received by Manufacturer11/09/2018
Initial Report FDA Received Date01/26/2018
Supplement Report FDA Received Date11/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age77 YR
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