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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA CR150 CEM SZ 4N RT; SIGMA KNEE PRIMARY : KNEE FEMORAL
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DEPUY INTERNATIONAL LTD - 8010379 SIGMA CR150 CEM SZ 4N RT; SIGMA KNEE PRIMARY : KNEE FEMORAL Back to Search Results
Model Number 1960-30-450
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 01/26/2021
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
(b)(4).The patient was revised to address instability and bony loss on tibia.No loosening reported and no surgical delay.Doi: (b)(6) 2013.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 CR150 CEM SZ 4N RT
Common Device Name
SIGMA KNEE PRIMARY : KNEE FEMORAL
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key12454631
Report Number1818910-2021-19871
Device Sequence Number3726137
Product Code JWH
UDI-Device Identifier10603295074977
UDI-Public10603295074977
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
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) 01/26/2021
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 Number1960-30-450
Device Catalogue Number196030450
Device Lot Number3584248
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/26/2021
Supplement Date Received by Manufacturer09/27/2021
Initial Report FDA Received Date09/10/2021
Supplement Report FDA Received Date09/28/2021
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
DEPUY1 GENTAMICIN CEMENT 40G; MBT CEM KEEL TIB TRAY SZ3; PFC SIGMARP CV TB/IN S4 10.0; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIGMA CR150 CEM SZ 4N RT; DEPUY1 GENTAMICIN CEMENT 40G; MBT CEM KEEL TIB TRAY SZ3; PFC SIGMARP CV TB/IN S4 10.0; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIGMA CR150 CEM SZ 4N RT
Outcome Attributed to Adverse Event Required Intervention;
Patient Age64 YR
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