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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG PS CEM FEM W/LUGS RT SZ3; SIGMA KNEE PRIMARY : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US SIG PS CEM FEM W/LUGS RT SZ3; SIGMA KNEE PRIMARY : KNEE FEMORAL Back to Search Results
Model Number 1960-73-500
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Joint Laxity (4526)
Date of Event 11/18/2020
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
Right knee revision - original surgery (b)(6) 2016.Removed femur, tray & insert due to instability and pain.Loosening implant to cement.
 
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 lot code was provided, a manufacturing records evaluation (mre) was not performed.H10 additional narrative:  added: g4 corrected: g1.
 
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Brand Name
SIG PS CEM FEM W/LUGS RT SZ3
Common Device Name
SIGMA KNEE PRIMARY : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10963107
Report Number1818910-2020-26419
Device Sequence Number910515
Product Code JWH
UDI-Device Identifier10603295075479
UDI-Public10603295075479
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K073529
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2020
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) 11/18/2020
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 Number1960-73-500
Device Catalogue Number196073500
Device Lot Number639827
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/18/2020
Supplement Date Received by Manufacturer01/07/2021
Initial Report FDA Received Date12/07/2020
Supplement Report FDA Received Date01/11/2021
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 2.5; SIGMA STAB XLK INS 2.5 10MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SIG MOD TIB TRAY CEM COCR 2.5; SIGMA STAB XLK INS 2.5 10MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
Outcome Attributed to Adverse Event Required Intervention;
Patient Age74 YR
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