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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 Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Event Date 07/22/2022
Event Type  Injury  
Event Description
Medical records received ad 5 oct 2022 were reviewed by clinician.On (b)(6) 2017 patient had a right total knee arthroplasty to address osteoarthritis of the right knee.Depuy components, including depuy patella and depuy cement x2 were used during this procedure.There were no intraoperative complications noted in the operative note.On (b)(6) 2022 the patient had a revision to address failed right total knee arthroplasty.The indications for surgery included: instability, and intraoperative finding, pain, recurrent effusions, of loosen tibial tray at the implant to cement interface.The femoral component was noted to be well fixed, but was removed.Competitor components were used during this procedure, the depuy patella was retained.Doi: (b)(6) 2017 dor: (b)(6) 2022 (right knee).
 
Manufacturer Narrative
Product complaint # (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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot a manufacturing record evaluation was performed for the finished device 545035500, lot 8450225 and no non-conformance's / manufacturing irregularities were identified.
 
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Brand Name
SMARTSET GHV GENTAMICIN 40G
Type of Device
BONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI  
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key15672605
MDR Text Key302404698
Report Number1818910-2022-21342
Device Sequence Number1
Product Code MBB
UDI-Device Identifier10603295174288
UDI-Public10603295174288
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 Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/26/2022
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 Date12/31/2018
Device Model Number5450-35-500
Device Catalogue Number545035500
Device Lot Number8450225
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/05/2022
Initial Date FDA Received10/26/2022
Supplement Dates Manufacturer Received11/03/2022
Supplement Dates FDA Received11/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2017
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 CR FEM RT SZ 5 NAR CEM.; ATTUNE CR RP INSRT SZ 5 6MM.; ATTUNE MEDIAL ANAT PAT 32MM.; ATTUNE RP TIB BASE SZ 4 CEM.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET GHV GENTAMICIN 40G.
Patient Outcome(s) Required Intervention;
Patient Age54 YR
Patient SexFemale
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