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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY CMW - 9610921 HARDINGE CEMENT RESTRICTOR; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

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DEPUY CMW - 9610921 HARDINGE CEMENT RESTRICTOR; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG Back to Search Results
Catalog Number 963204000
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2023
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Surgeon inserted hardinge cement restrictor into femoral canal size 3 c-stem has been prepared.Two of the hardinge fins snapped off inside the patient.Surgeon recovered the snapped pieces and continued the operation.
 
Manufacturer Narrative
Product complaint # (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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Additional information was received and stated that there were no adverse events for the patient.The surgeon upon seeing the fins had to spend a couple of minutes picking them out of the femoral canal.Once complete, he continued with the operation as expected.
 
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 a manufacturing record evaluation (nc search) was performed for the finished device product code - (b)(4), lot code - d23021156 and no non-conformances / manufacturing irregularities were identified.
 
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Brand Name
HARDINGE CEMENT RESTRICTOR
Type of Device
HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
Manufacturer (Section D)
DEPUY CMW - 9610921
cornford rd
cornford rd
blackpool FY4 4 QQ
UK  FY4 4QQ
Manufacturer (Section G)
DEPUY CMW - 9610921
cornford rd
blackpool LS11 8 DT
UK   LS11 8 DT
Manufacturer Contact
kate karberg
700 orthpaedic dr.
warsaw, IN 46581
3035526892
MDR Report Key17155659
MDR Text Key317847324
Report Number1818910-2023-12474
Device Sequence Number1
Product Code JDK
Combination Product (y/n)N
Reporter Country CodeNZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number963204000
Device Lot NumberD23021156
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexMale
Patient Weight100 KG
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