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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
Model Number 1294-01-040
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 01/14/2021
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 was revised to address pain and loosening of the femoral component at the cement to implant interface.Unknown cement was used.No further information is available.Doi: (b)(6) 2007, dor: (b)(6) 2021, right 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
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 46581 0988
MDR Report Key11236753
Report Number1818910-2021-01875
Device Sequence Number19864860
Product Code NJL
UDI-Device Identifier10603295021551
UDI-Public10603295021551
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Device Explanted Year2021
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) 01/14/2021
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 Number1294-01-040
Device Catalogue Number129401040
Device Lot Number2466261
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/14/2021
Supplement Date Received by Manufacturer03/01/2021
Initial Report FDA Received Date01/27/2021
Supplement Report FDA Received Date03/02/2021
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
LCS COMP RP INSERT STD 12.5MM; LCS COMPLETE FEM CEM R STD; MBT CEM KEEL TIB TRAY SZ2.5; LCS COMP RP INSERT STD 12.5MM; LCS COMPLETE FEM CEM R STD; MBT CEM KEEL TIB TRAY SZ2.5
Outcome Attributed to Adverse Event Required Intervention;
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