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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ2 L; SIGMA KNEE PRIMARY : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ2 L; SIGMA KNEE PRIMARY : KNEE FEMORAL Back to Search Results
Model Number 1960-40-200
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); No Code Available (3191)
Date of Event 05/29/2020
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
The patient was revised due to pain.No additional information.Doi: (b)(6) 2018; dor: (b)(6) 2020; left 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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
SIGMA PS CEM FEM SZ2 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 Key10133791
Report Number1818910-2020-13447
Device Sequence Number11743183
Product Code JWH
UDI-Device Identifier10603295075028
UDI-Public10603295075028
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K073529
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/29/2020
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 Number1960-40-200
Device Catalogue Number196040200
Device Lot Number8563268
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/29/2020
Supplement Date Received by Manufacturer07/14/2020
Initial Report FDA Received Date06/09/2020
Supplement Report FDA Received Date07/15/2020
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 CEM KEEL TIB TRAY SZ1.5.; PFC SIGMA/OV DOME PAT 3 PEG,32.; PFC SIGMARP STB TB IN 2 10.0.; SIGMA PS CEM FEM SZ2 L.; MBT CEM KEEL TIB TRAY SZ1.5; PFC SIGMA/OV DOME PAT 3 PEG,32; PFC SIGMARP STB TB IN 2 10.0; SIGMA PS CEM FEM SZ2 L
Outcome Attributed to Adverse Event Required Intervention;
Patient Weight73
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