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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 SZ4; SIGMA REVISION IMPLANT : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ4; SIGMA REVISION IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 96-0089
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 12/07/2020
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 above mentioned knee endoprosthesis was implanted in (b)(6) in 2002.Since 2013 loosening of the prosthesis and fracture of the tibial stem is known.Due to multiple internal diseases the patient was not able to undergo surgery up to now.Now, knee-tep removal was performed because of knee-tep loosening and stem-fracture." doi: (b)(6) 2002, dor: (b)(6) 2020, right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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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 Key11893254
Report Number1818910-2021-11376
Device Sequence Number3633668
Product Code JWH
UDI-Device Identifier10603295232568
UDI-Public10603295232568
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K952830
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2002
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/30/2021
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 Number96-0089
Device Catalogue Number960089
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/30/2021
Supplement Date Received by Manufacturer06/02/2021
Initial Report FDA Received Date05/27/2021
Supplement Report FDA Received Date06/02/2021
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
P.F.C.* TIB STM EXT 4/5/6 60MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC* MOD PLUS TIBIAL TRAY SZ 4; PFC*SIGMA TC3 FEM RT SZ4; PFC*SIGMA TC3 INS 15MM, SZ 4; P.F.C.* TIB STM EXT 4/5/6 60MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC* MOD PLUS TIBIAL TRAY SZ 4; PFC*SIGMA TC3 FEM RT SZ4; PFC*SIGMA TC3 INS 15MM, SZ 4
Outcome Attributed to Adverse Event Required Intervention;
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