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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL Back to Search Results
Model Number 96-0003
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/16/2021
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
Aseptic loosening of sigma size 3 cr femur.Entire knee was revised to attune revision.Left.I was not provided the lot #s.The tibia was revised on (b)(6) 2017.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.
 
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Common Device Name
SIGMA KNEE PRIMARY : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12123455
Report Number1818910-2021-14393
Device Sequence Number3966056
Product Code JWH
UDI-Device Identifier10603295231950
UDI-Public10603295231950
Combination Product (Y/N)N
Initial Reporter StateVT
Initial Reporter CountryUS
PMA/510(K) Number
K943462
Number of Events Summarized1
Summary Report (Y/N)N
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) 06/16/2021
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 Number96-0003
Device Catalogue Number960003
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/16/2021
Supplement Date Received by Manufacturer08/04/2021
Initial Report FDA Received Date07/06/2021
Supplement Report FDA Received Date08/04/2021
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 3; MBT TRAY SLEEVE POR M/L 29MM; PFC SIGMARP CV TB/IN S3 17.5; PFC*SIGMA C/R NPOR FEM LT SZ 3; SIGTIBCEMSTM 13X30 1.5/2/2.5/3; MBT REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 29MM; PFC SIGMARP CV TB/IN S3 17.5; PFC*SIGMA C/R NPOR FEM LT SZ 3; SIGTIBCEMSTM 13X30 1.5/2/2.5/3
Outcome Attributed to Adverse Event Required Intervention;
Patient Age61 YR
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