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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HARDINGE CEMENT RESTRICTOR; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
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DEPUY INTERNATIONAL LTD - 8010379 HARDINGE CEMENT RESTRICTOR; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG Back to Search Results
Catalog Number 963204000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/15/2021
Event Type  Injury  
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 Description
Revision and removal of all previous revision components.Revision was required due to infection being present with swelling and fluid within the knee.Doi: unknown.Dor:(b)(6) 2021.Unknown knee.
 
Event Description
Additional information received indicated that the surgeon suspected an underlying infection has been the cause of all the revisions performed.Affected side is left knee.
 
Manufacturer Narrative
Product complaint # : pc-(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 clinical code: appropriate term / code not available (e2402) is used to capture infection (e19).A concomitant product was identified to be a competitor product used in conjunction with the previously reported adverse event.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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
HARDINGE CEMENT RESTRICTOR
Type of Device
HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key11887250
MDR Text Key261230728
Report Number1818910-2021-11267
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
PMA/PMN Number
K940743
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 05/15/2021
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
Device Operator Health Professional
Device Catalogue Number963204000
Device Lot NumberD19061358
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/15/2021
Initial Date FDA Received05/26/2021
Supplement Dates Manufacturer Received06/23/2021
08/09/2021
Supplement Dates FDA Received07/09/2021
08/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
HARDINGE CEMENT RESTRICTOR; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 61MM; PALACOS CEMENT; PFC SIGMA FEM POST AUG SZ5 4MM; PFC SIGMA FEM POST AUG SZ5 4MM; PFC*SIGMA DIS AUG 8MM,SZ5,LEFT; PFC*SIGMA DIS AUG 8MM,SZ5,LEFT; PFC*SIGMA TC3 FEM LEFT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SIGTIBCEMSTM 13X30 1.5/2/2.5/3; TC3 RP TIBIAL INSERT S5,10.0; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 115X16MM FLUTED
Patient Outcome(s) Required Intervention;
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