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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 Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Loss of Range of Motion (2032); Joint Laxity (4526)
Event Date 03/13/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. Dmf# 13704 trade name gentamicin sulphate active ingredient(s) gentamicin sulphate dosage form powder strength 1. 0g active in our cements. 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 attune total knee to treat degenerative joint disease. The patella was resurfaced and depuy cement x 2 was utilized. There were no indicated intra-operative complications. Patient underwent a left knee revision to address instability, decreased range of motion, hemarthrosis, adhesion, and tibial tray and femoral component loosening at the cement to implant interface. The surgeon noted it band compromise. The tibial tray, tibial insert, and femoral component were revised. The patellar component was retained. The patient was revised with competitor products and cement. There were no indicated intra-operative complications. Doi: (b)(6) 2017 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)
DEPUY CMW - 9610921
cornford rd
blackpool FY4 4 QQ
UK FY4 4QQ
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11755568
MDR Text Key248443661
Report Number1818910-2021-09333
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
Type of Report Initial
Report Date 04/20/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2018
Device MODEL Number5450-35-500
Device Catalogue Number545035500
Device LOT Number8356593
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/11/2016
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: 04/30/2021 Patient Sequence Number: 1
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