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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 SZ2.5; SIGMA REVISION IMPLANT : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ2.5; SIGMA REVISION IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 96-0092
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 03/03/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(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 painful right knee.No additional information.No surgical delay.Doi: (b)(6) 2014; 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 Key11517115
Report Number1818910-2021-05478
Device Sequence Number17102582
Product Code JWH
UDI-Device Identifier10603295232599
UDI-Public10603295232599
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K952830
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
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) 03/03/2021
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? No
Operator of Device Health Professional
Device Model Number96-0092
Device Catalogue Number960092
Device Lot Number473217
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/03/2021
Supplement Date Received by Manufacturer04/19/2021
Initial Report FDA Received Date03/18/2021
Supplement Report FDA Received Date04/20/2021
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
PFC SIG FEM POST AUG SZ2.5 4MM; PFC*SIGMA DIS AUG4MM,S2.5,RGHT; PFC*SIGMA DIS AUG8MM,S2.5,RGHT; PFC*SIGMA TC3 FEM RT SZ2.5; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S2.5,10.0; PFC SIG FEM POST AUG SZ2.5 4MM; PFC SIGMA DIS AUG4MM,S2.5,RGHT; PFC SIGMA DIS AUG8MM,S2.5,RGHT; PFC SIGMA TC3 FEM RT SZ2.5; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S2.5,10.0
Outcome Attributed to Adverse Event Required Intervention;
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