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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSETGMV ENDURANCE GENT 40G; BONE CEMENT : BONE CEMENT
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DEPUY CMW - 9610921 SMARTSETGMV ENDURANCE GENT 40G; BONE CEMENT : BONE CEMENT Back to Search Results
Catalog Number 3105040
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Cyst(s) (1800); Pain (1994); No Code Available (3191)
Event Date 10/21/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Revision surgery was required for what was suspected to be a failed or loose tibia tray.According to the surgeon, the patient had been complaining of pain for sometime and there was a cyst that formed close to the tibial tray itself.Original surgery was (b)(6) 2016.During the revision, it was clear to see that the tray was in fact debonded from the cement and loose.
 
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: 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 report, a follow-up report will be filed as appropriate.
 
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.Device history lot: product/lot information is not available.
 
Event Description
Additional information was received stating that the tibial insert was fractured during implant removal at the time of revision.
 
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.
 
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Brand Name
SMARTSETGMV ENDURANCE GENT 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 Key10851934
MDR Text Key216612483
Report Number1818910-2020-24742
Device Sequence Number1
Product Code MBB
Combination Product (y/n)N
PMA/PMN Number
K081163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3105040
Was Device Available for Evaluation? No
Date Manufacturer Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 5 NAR CEM; ATTUNE PS RP INSRT SZ 5 12MM; ATTUNE RP TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 5 NAR CEM; ATTUNE PS RP INSRT SZ 5 12MM; ATTUNE RP TIB BASE SZ 4 CEM
Patient Outcome(s) Required Intervention;
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