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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 Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/27/2020
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

Inner packing damaged. It was reported that during the surgery of total knee replacement operation, opened the out-box, noted the inner packing was damaged (one part was not sealed) as the photos show. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.

 
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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 Key10364442
MDR Text Key201605982
Report Number1818910-2020-17537
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
PMA/PMN NumberK033563
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 07/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number3095040
Device LOT Number9400183
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/12/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/04/2020 Patient Sequence Number: 1
Treatment
SMARTSET GHV GENTAMICIN 40G
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