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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE FEM CEM R STD+; LCS COMPLETE : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US LCS COMPLETE FEM CEM R STD+; LCS COMPLETE : KNEE FEMORAL Back to Search Results
Catalog Number 129401050
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 12/11/2018
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.(b)(4).
 
Event or Problem Description
Patient revised due to loose components.
 
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.
 
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Brand Name
LCS COMPLETE FEM CEM R STD+
Common Device Name
LCS COMPLETE : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8227394
Report Number1818910-2019-80173
Device Sequence Number19307869
Product Code JWH
UDI-Device Identifier10603295021568
UDI-Public10603295021568
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/11/2018
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 Number129401050
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/11/2018
Supplement Date Received by Manufacturer01/15/2019
Initial Report FDA Received Date01/08/2019
Supplement Report FDA Received Date01/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age70 YR
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