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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 Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)
Event Date 03/13/2018
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

Patient called complaining about her left knee. She will be scheduled for a revision on (b)(6) 2018 and she will visit her surgeon on the 20th for follow up. She had her implant on (b)(6) 2014. Patient tripped/fell, pain going up to the hip, on grouching mode because of the pain. Used to exercise three times a day but she can't do it now because of the pain. The knee cap needs to be replaced and the doctor said 90% part of the knee will be replaced. She tried to reached out to the hospital to get the medical records but to no avail. She is a retiree and this has caused her so much stressed. Medical records received on 17 jun 2019 were reviewed for mdr reportability on 31 july 2019. On (b)(6) 2018, the patient underwent a left knee revision due to pain, instability, and tibial tray loosening at the cement to implant interface. There was no cement attached to the tibial tray. The tibial tray and tibial insert were the only products revised. Two depuy cement products were used during the primary operation. Doi: (b)(6) 2014; dor: (b)(6) 2018; left knee. Doi: (b)(6) 2014: dor: (b)(6) 2018, (schedule), (left 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.

 
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Brand NameSMARTSET GHV GENTAMICIN 40G
Type of DeviceBONE 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
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8910274
MDR Text Key154894785
Report Number1818910-2019-101642
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial,Followup,Followup
Report Date 03/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2016
Device MODEL Number5450-35-500
Device Catalogue Number545035500
Device LOT Number7807538
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/16/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/20/2019 Patient Sequence Number: 1
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