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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); No Code Available (3191)
Event Date 10/29/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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 right primary attune to treat pain secondary to degenerative joint disease.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient received a right tka revision to treat pain secondary to loosening.Upon entering the joint, the surgeon and excised scar tissue.The tibial tray was loosened and debonded at the cement to implant interface.The patella was well-fixed but revised to accommodate the new components.The femoral component was well-fixed but revised.There was no reported product problem with the revised tibial insert.The patient was implanted with competitor products.The procedure was completed without complications.Doi: (b)(6) 2017, doi: (b)(6) 2019, right knee.
 
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.
 
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.
 
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Brand Name
SMARTSET GHV GENTAMICIN 40G
Type of Device
BONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY CMW - 9610921
cornford rd
blackpool FY4 4 QQ
UK  FY4 4QQ
MDR Report Key10333640
MDR Text Key200652418
Report Number1818910-2020-17001
Device Sequence Number1
Product Code MBB
UDI-Device Identifier10603295174288
UDI-Public10603295174288
Combination Product (y/n)N
PMA/PMN Number
K081163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 07/16/2020
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 Expiration Date03/31/2019
Device Model Number5450-35-500
Device Catalogue Number545035500
Device Lot Number8525085
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/16/2020
Initial Date FDA Received07/28/2020
Supplement Dates Manufacturer Received09/02/2020
09/02/2020
Supplement Dates FDA Received09/02/2020
09/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE PS FEM RT SZ 5 NAR CEM; ATTUNE PS RP INSRT SZ 5 8MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; ATTUNE MEDIAL ANAT PAT 32 MM; ATTUNE PS FEM RT SZ 5 NAR CEM; ATTUNE PS RP INSRT SZ 5 8 MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
Patient Outcome(s) Required Intervention;
Patient Age61 YR
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