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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT

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DEPUY ORTHOPAEDICS INC US 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 Loss of Range of Motion (2032); Synovitis (2094); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/12/2019
Event Type  Injury  
Manufacturer Narrative

Product complaint #: (b)(4). Initial reporter occupation: lawyer. Dmf# - (b)(4), trade name - gentamicin sulphate, active ingredient(s) - gentamicin sulphate, dosage form - powder, strength - 1. 0g active in our cements. (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

Patient received a left primary attune tka to treat post-traumatic osteoarthritis. The patella was resurfaced and depuy cement x 2 was utilized. The procedure was completed without complications. Patient received a left knee revision to treat suspected to loosening. Upon entering the joint, synovitis and bony overgrowth was debrided, and tight flexion identified. The femoral component was loose at the cement to bone interface and revised. The tibial tray was loosened and debonded at the cement to implant interface and revised. There was no reported product problem with the revised tibial insert. Patella was retained. The patient was revised with competitor revision components utilizing competitor cement. The procedure was completed without complications. Doi: (b)(6) 2014, dor: (b)(6) 2019, left knee.

 
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Brand NameSMARTSET GHV GENTAMICIN 40G
Type of DeviceBONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
CMW MFG & MATERIAL WAREHOUSE
cornford rd
blackford FY44Q Q
UK FY44QQ
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key11659105
MDR Text Key246684474
Report Number1818910-2021-07836
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK081163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/31/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2021
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 Number7795159
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 Received05/06/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/07/2014
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: 04/13/2021 Patient Sequence Number: 1
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