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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 Problems Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 07/10/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. (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

Medical records received 23 jul 2018. Medical records reviewed for mdr reportability. Patient underwent a left tka and the tibial tray and insert were later revised for start-up pain and mid stance laxity. Intraoperative findings included decreased range of motion and loosening of the tibial tray at cement to implant and cement to bone interfaces. Surgeon mentions the previous tibial tray had a 2mm overhang from the anterior/medial tibia. Doi: (b)(6) 2016. Dor: (b)(6) 2017 (tray and insert only).

 
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Brand NameSMARTSET GMV 40G US EO
Type of DeviceBONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY CMW - 9610921
cornford rd
blackpool IN 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 drive
warsaw, IN 46581-0988
6107428552
MDR Report Key8718595
MDR Text Key148743123
Report Number1818910-2019-96420
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2019
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2020
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 TREATMENT DATA
Date Received: 06/20/2019 Patient Sequence Number: 1
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