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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
Model Number 5450-35-500
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 05/28/2019
Event Type  Injury  
Manufacturer Narrative

(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

Right knee rev original surgery done (b)(6) 2015. Patient complained of pain and range of motion concerns. Removed patella, poly and tray. Tibial component was loose, implant to cement.

 
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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameSMARTSET GHV GENTAMICIN 40G
Type of DeviceBONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY CMW - 9610921
cornford rd
blackpool IN 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 Key8704537
MDR Text Key148189818
Report Number1818910-2019-96119
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 05/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5450-35-500
Device Catalogue Number545035500
Device LOT Number8069452
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 Received08/31/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/18/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/17/2019 Patient Sequence Number: 1
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