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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 5 12.5MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT
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DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 5 12.5MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT Back to Search Results
Model Number 95-1051
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Code Pain (1994)
Date of Event 01/19/2021
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
The patient was revised to address pain and loosening of the unknown component at the bone to cement and cement to implant interfaces.Depuy cement was used.No additional information.There was loosening and significant delamination of the patella and some on the tibial insert.The patella wasn't loose, but there was loosening on the tibial tray and femoral component.Doi: (b)(6) 2007, 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 lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
PFC SIG RPF INS SZ 5 12.5MM
Common Device Name
PFC SIGMA RP-F : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key11285687
Report Number1818910-2021-02465
Device Sequence Number19793886
Product Code NJL
UDI-Device Identifier10603295230465
UDI-Public10603295230465
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
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) 01/19/2021
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 Number95-1051
Device Catalogue Number951051
Device Lot NumberZ39C14000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/19/2021
Supplement Date Received by Manufacturer03/05/2021
Initial Report FDA Received Date02/05/2021
Supplement Report FDA Received Date03/08/2021
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
MBT CEM KEEL TIB TRAY SZ5; PFC SIG RPF CEM FEM SZ 5 RT; PFC SIG RPF INS SZ 5 12.5MM; PFC*SIGMA/OV/DOME PAT 3PEG,41; SMARTSET HV BONE CEMENT 40G; MBT CEM KEEL TIB TRAY SZ5; PFC SIG RPF CEM FEM SZ 5 RT; PFC SIG RPF INS SZ 5 12.5MM; PFC*SIGMA/OV/DOME PAT 3PEG,41; SMARTSET HV BONE CEMENT 40G
Outcome Attributed to Adverse Event Required Intervention;
Patient Weight99
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