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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ4 L; SIGMA KNEE PRIMARY : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ4 L; SIGMA KNEE PRIMARY : KNEE FEMORAL Back to Search Results
Model Number 1960-40-400
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 01/15/2021
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 the left total knee to address infection.Date of implantation: (b)(6) 2017, date of revision: (b)(6) 2021, (left knee).Treatment: explantation of all implants.
 
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Brand Name
SIGMA PS CEM FEM SZ4 L
Common Device Name
SIGMA KNEE PRIMARY : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11251546
Report Number1818910-2021-02079
Device Sequence Number2552076
Product Code JWH
UDI-Device Identifier10603295075059
UDI-Public10603295075059
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,study
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date (Section B) 01/20/2021
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? No
Operator of Device Health Professional
Device Model Number1960-40-400
Device Catalogue Number196040400
Device Lot Number8530613
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/20/2021
Supplement Date Received by Manufacturer01/20/2021
02/23/2021
Initial Report FDA Received Date01/29/2021
Supplement Report FDA Received Date02/10/2021
03/02/2021
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
DEPUY CMW 3 40G.; DEPUY CMW 3 40G.; MBT CEM KEEL TIB TRAY SZ4.; PFC*SIGMA/OV/DOME PAT 3PEG,38.; SIG RP AOX STB INS SZ4 12.5.; SIGMA PS CEM FEM SZ4 L.; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX STB INS SZ4 12.5; SIGMA PS CEM FEM SZ4 L
Outcome Attributed to Adverse Event Required Intervention;
Patient Age65 YR
Patient Weight111
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