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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG MOD TIB TRAY CEM COCR 2; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIG MOD TIB TRAY CEM COCR 2; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 1581-20-000
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 05/04/2021
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 aseptic loosening of the tibial component at the cement to implant interface.A depuy cement was used.No surgical delay.Doi: (b)(6) 2012.Dor: (b)(6) 2021.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.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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
SIG MOD TIB TRAY CEM COCR 2
Common Device Name
SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11833054
Report Number1818910-2021-10464
Device Sequence Number16942314
Product Code JWH
UDI-Device Identifier10603295063810
UDI-Public10603295063810
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K032151
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
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) 05/04/2021
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 Number1581-20-000
Device Catalogue Number158120000
Device Lot Number3433195
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/04/2021
Supplement Date Received by Manufacturer06/29/2021
Initial Report FDA Received Date05/17/2021
Supplement Report FDA Received Date06/30/2021
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
SIG MOD TIB TRAY CEM COCR 2; SIGMA PS CEM FEM SZ2.5 L; SIGMA STAB GVF INS 2 10MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SIG MOD TIB TRAY CEM COCR 2; SIGMA PS CEM FEM SZ2.5 L; SIGMA STAB GVF INS 2 10MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
Outcome Attributed to Adverse Event Required Intervention;
Patient Age75 YR
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