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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ3 L; SIGMA KNEE PRIMARY : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ3 L; SIGMA KNEE PRIMARY : KNEE FEMORAL Back to Search Results
Model Number 1960-40-300
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 12/10/2020
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
The patient was revised to address instability and loosening of the femoral and tibial components at the cement to implant interface.Unknown cement was used.Doi: (b)(6) 2011; 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.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 SZ3 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 Key11077154
Report Number1818910-2020-27652
Device Sequence Number1257602
Product Code JWH
UDI-Device Identifier10603295075042
UDI-Public10603295075042
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K073529
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
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) 12/10/2020
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? Yes
Operator of Device Health Professional
Device Model Number1960-40-300
Device Catalogue Number196040300
Device Lot Number3264198
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/10/2020
Supplement Date Received by Manufacturer01/25/2021
Initial Report FDA Received Date12/28/2020
Supplement Report FDA Received Date01/27/2021
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
MBT CEM KEEL TIB TRAY SZ2.5; PFC SIGMARP STB TB IN 3 15.0; MBT CEM KEEL TIB TRAY SZ2.5; PFC SIGMARP STB TB IN 3 15.0
Outcome Attributed to Adverse Event Required Intervention;
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