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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM LT SZ 4N; SIGMA KNEE PRIMARY : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM LT SZ 4N; SIGMA KNEE PRIMARY : KNEE FEMORAL Back to Search Results
Model Number 94-0019
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 05/18/2020
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 to address instability.No surgical delay.Doi: (b)(6) 2019; 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
SIG C/R POROCOAT FEM LT SZ 4N
Common Device Name
SIGMA KNEE PRIMARY : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10102700
Report Number1818910-2020-12850
Device Sequence Number3082461
Product Code JWH
UDI-Device Identifier10603295223450
UDI-Public10603295223450
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
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) 05/18/2020
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 Number94-0019
Device Catalogue Number940019
Device Lot Number735998
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/18/2020
Supplement Date Received by Manufacturer07/01/2020
Initial Report FDA Received Date05/29/2020
Supplement Report FDA Received Date07/02/2020
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 POR KEEL TIB TRAY SZ3; SIG RP AOX CRV INS SZ4 15
Outcome Attributed to Adverse Event Required Intervention;
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