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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ3; SIGMA REVISION IMPLANT : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ3; SIGMA REVISION IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 96-0088
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 02/15/2021
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 femoral component at the cement to bone and cement to implant interface.Competitor cement was used.Doi: (b)(6) 2018, 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.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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Common Device Name
SIGMA REVISION IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11388399
Report Number1818910-2021-03940
Device Sequence Number17110126
Product Code JWH
UDI-Device Identifier10603295232551
UDI-Public10603295232551
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
K952830
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
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) 02/15/2021
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 Number96-0088
Device Catalogue Number960088
Device Lot NumberJ0003A
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/15/2021
Supplement Date Received by Manufacturer03/30/2021
Initial Report FDA Received Date02/26/2021
Supplement Report FDA Received Date04/01/2021
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
COMPETITOR CEMENT; PFC SIGMA FEM POST AUG SZ3 4MM; PFC SIGMA FEM POST AUG SZ3 8MM; PFC SIGMARP STB TB IN 3 17.5; PFC*SIGMA DIS AUG 4MM,SZ3,RGHT; PFC*SIGMA DIS AUG 4MM,SZ3,RGHT; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; UNIVERSAL STEM 75X16MM FLUTED
Outcome Attributed to Adverse Event Required Intervention;
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