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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ4N R; SIGMA KNEE PRIMARY : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ4N R; SIGMA KNEE PRIMARY : KNEE FEMORAL Back to Search Results
Model Number 1960-50-450
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 07/19/2021
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
Patient was revised due to loosening of the tibial and femoral component at the bone to cement and cement to implant interface.Doi: (b)(6) 2015, dor: (b)(6) 2021, right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
SIGMA PS CEM FEM SZ4N R
Common Device Name
SIGMA KNEE PRIMARY : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12298044
Report Number1818910-2021-17448
Device Sequence Number4585658
Product Code JWH
UDI-Device Identifier10603295075158
UDI-Public10603295075158
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
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) 07/19/2021
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 Number1960-50-450
Device Catalogue Number196050450
Device Lot Number625125
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/19/2021
Supplement Date Received by Manufacturer08/23/2021
Initial Report FDA Received Date08/09/2021
Supplement Report FDA Received Date08/24/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
COMPETITOR CEMENT; MBT CEM KEEL TIB TRAY SZ3; PFC SIGMARP STB TB IN 4 12.5; SIGMA PS CEM FEM SZ4N R
Outcome Attributed to Adverse Event Required Intervention;
Patient Weight66
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