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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT

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DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT Back to Search Results
Catalog Number 3095040
Device Problems Fluid Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2020
Event Type  Malfunction  
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

A bilateral attune case was done today in (b)(6). Before implanting the implant, an opening was found on the ghv cement (ref: 3095-040) inner sterile pack while the outer layers were perfectly sealed. Cement powder is leaking out from the sterile pack. However the issue was noticed and the cement is discarded before passing it to the scrub nurse. Another pack of cement in good condition was used to replace the faulty one. Was surgery delayed due to the reported event? no. Was procedure successfully completed? yes. Were fragments generated? unknown. If yes, were they removed easily without additional intervention? unknown. Patient status/ outcome / consequences: no. Was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: unknown. Is the patient part of a clinical study: unknown. Ip-(b)(6). Device property of: none. Device in possession of: none. By checking this box i certify that all information that are known/available has been disclosed. If any new information will be made available, the additional information will be submitted through cst. True.

 
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Brand NameSMARTSET GHV GENTAMICIN 40G
Type of DeviceBONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY CMW - 9610921
cornford rd
blackpool FY4 4 QQ
UK FY4 4QQ
Manufacturer (Section G)
DEPUY CMW - 9610921
cornford rd
blackpool FY4 4 QQ
UK FY4 4QQ
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10279788
MDR Text Key203894872
Report Number1818910-2020-15964
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeMY
PMA/PMN NumberK081163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/05/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number3095040
Device LOT Number9292938
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/05/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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