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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

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DEPUY CMW - 9610921 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT Back to Search Results
Model Number 5450-50-501
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 06/22/2021
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
Clinical notification received for revision of left total knee to address infection date of implantation: (b)(6) 2019.Date of revision: (b)(6) 2021.(left knee).Treatment: revision of all products (femur construct, tibial construct, insert, and patella components).
 
Manufacturer Narrative
Product complaint # (b)(4).
 
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.H10 additional narrative: added: a2 (date of birth) and b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d6a.
 
Event Description
Medical records received indicated that the primary operative notes and the first revision procedure notes were not provided within this set of medical records.It is unknown, at this time, what the manufacturer of the primary implants or first revision surgery were.Unknown if depuy ¿ dates of primary and first revision surgeries also not provided.Revision operative notes (b)(6) 2019 indicate the patient received a left total knee revision due to infection.It is unknown if depuy products were implanted at this surgery.Re-implantation operative notes (b)(6) 2019 indicate the patient received a left total knee re-implantation due to infection markers were satisfactory for re-implantation.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2021 indicate the patient received a left total knee revision due to infection.The surgery was completed without indication of complication by the surgeon.((b)(4)) revision operative notes (b)(6) 2021 indicate the patient received a left total knee revision due to pain, swelling and hematogenous spread of infection.The surgery was completed without indication of complication by the surgeon.((b)(4)).
 
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 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
SMARTSET GMV 40G US EO
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 Key12705187
MDR Text Key278599579
Report Number1818910-2021-23709
Device Sequence Number1
Product Code MBB
UDI-Device Identifier10603295174295
UDI-Public10603295174295
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,Followup
Report Date 10/05/2021
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? No
Device Operator Health Professional
Device Model Number5450-50-501
Device Catalogue Number545050501
Device Lot Number8941469
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/15/2021
Initial Date FDA Received10/27/2021
Supplement Dates Manufacturer Received10/15/2021
11/03/2021
11/23/2021
Supplement Dates FDA Received10/27/2021
11/18/2021
11/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2018
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 CRS FEMORAL LT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 14MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE POS FEM AUG SZ 8 4MM; ATTUNE POS FEM AUG SZ 8 8MM; ATUN FEM SLV M/L 40MM FULL POR; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM20X60MM; ATUNE REV RP TIB BASE SZ 7 CEM; DEPUY CMW 2 20G; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; UNK ATTUNE KNEE PATELLA; ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 14MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE POS FEM AUG SZ 8 4MM; ATTUNE POS FEM AUG SZ 8 8MM; ATUN FEM SLV M/L 40MM FULL POR; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM20X60MM; ATUNE REV RP TIB BASE SZ 7 CEM; DEPUY CMW 2 20G; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; UNK ATTUNE KNEE PATELLA
Patient Outcome(s) Required Intervention;
Patient Age78 YR
Patient SexMale
Patient Weight101 KG
Patient EthnicityNon Hispanic
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