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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA DIS AUG 4MM,SZ3,LEFT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
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DEPUY ORTHOPAEDICS INC US PFC*SIGMA DIS AUG 4MM,SZ3,LEFT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY Back to Search Results
Model Number 96-0860
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 05/29/2020
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
It was reported that the patient's knee was infected.All revision components were removed and antibiotic spacer was put in.Doi: (b)(6) 2020, 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 synthese 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 ACCESSORY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10149198
Report Number1818910-2020-13636
Device Sequence Number2094218
Product Code JWH
UDI-Device Identifier10603295234265
UDI-Public10603295234265
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K952830
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/29/2020
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? No
Operator of Device Health Professional
Device Model Number96-0860
Device Catalogue Number960860
Device Lot NumberH48102
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/29/2020
Supplement Date Received by Manufacturer07/14/2020
Initial Report FDA Received Date06/12/2020
Supplement Report FDA Received Date07/15/2020
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 REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 29MM; PFC*SIGMA DIS AUG 4MM,SZ3,LEFT; PFC*SIGMA DIS AUG 8MM,SZ3,LEFT; SIG RP AOX STB INS SZ3 15; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SIGMA PS CEM FEM SZ3 L; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED; MBT REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 29MM; PFC*SIGMA DIS AUG 4MM,SZ3,LEFT; PFC*SIGMA DIS AUG 8MM,SZ3,LEFT; SIG RP AOX STB INS SZ3 15; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SIGMA PS CEM FEM SZ3 L; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED
Outcome Attributed to Adverse Event Required Intervention;
Patient Age65 YR
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