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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

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DEPUY IRELAND - 9616671 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT Back to Search Results
Model Number 5450-50-501
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Insufficient Information (4580)
Event Date 09/28/2022
Event Type  Injury  
Event Description
Patient was revised due to loosening of the tibial component at the bone to cement interface.Depuy cement was used.Doi: (b)(6) 2011, dor: (b)(6) 2022, affected side: left knee.
 
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.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 (mre), was not possible because the required lot code was not provided.
 
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Brand Name
SMARTSET GMV 40G US EO
Type of Device
BONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY CMW - 9610921
cornford rd
blackpool FY4 4 QQ
UK   FY4 4QQ
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key15649517
MDR Text Key302166890
Report Number1818910-2022-21046
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/21/2022
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 Model Number5450-50-501
Device Catalogue Number545050501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/28/2022
Initial Date FDA Received10/21/2022
Supplement Dates Manufacturer Received11/11/2022
Supplement Dates FDA Received11/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 PS RP INSRT SZ8 5MM,; ATTUNE RP TIB BASE SZ 8 CEM.; SMARTSET GMV 40G US EO,; SMARTSET GMV 40G US EO,
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient SexMale
Patient Weight109 KG
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