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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT

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DEPUY CMW - 9610921 DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT Back to Search Results
Model Number 5450-31-500
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Pain (1994); Swelling/ Edema (4577); Insufficient Information (4580)
Event Date 04/05/2016
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).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
Subject id: (b)(4).Study: dots.Clinical adverse event received for osteolysis/luciencies/migration/loosening - femoral event is serious and is considered severe event is definitely related to device and is definitely related to procedure.Date of implantation: (b)(6) 2013.Date of event (onset): (b)(6) 2016.(right knee).Treatment: osteolysis/lucencies were noted (b)(6) 2016 and which progressivly worsened until the knee was revised on (b)(6) 2017.Femur, tibial tray,and insert were revised.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Primary operative notes (b)(6) 2013 indicate the patient received a right total knee replacement due to end stage osteoarthritis.The patella was resurfaced, and depuy cement was utilized.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2017 indicate the patient received a right total knee revision due to osteolysis, effusion and pain.Upon entering the joint, the femoral component was noted to be grossly loose.The femoral, tibial and insert components revised.The surgery was completed without indication of complication by the surgeon.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays and photographs were reviewed, and the reported event cannot be confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
DEPUY1 GENTAMICIN CEMENT 40G
Type of Device
BONE 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 dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12703858
MDR Text Key278553883
Report Number1818910-2021-23635
Device Sequence Number1
Product Code MBB
UDI-Device Identifier10603295174264
UDI-Public10603295174264
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K081163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5450-31-500
Device Catalogue Number545031500
Device Lot Number3498649
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/14/2021
Initial Date FDA Received10/27/2021
Supplement Dates Manufacturer Received10/20/2021
11/17/2021
Supplement Dates FDA Received10/28/2021
11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ 8 8MM; ATTUNE RP TIB BASE SZ 8 CEM; DEPUY CMW 1 40G; DEPUY1 GENTAMICIN CEMENT 40G; ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ 8 8MM; ATTUNE RP TIB BASE SZ 8 CEM; DEPUY CMW 1 40G; DEPUY1 GENTAMICIN CEMENT 40G
Patient Outcome(s) Required Intervention;
Patient Age58 YR
Patient SexMale
Patient Weight86 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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