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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DEPUY/CMW 2G BONE CEMENT : BONE CEMENT

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DEPUY ORTHOPAEDICS, INC. 1818910 DEPUY/CMW 2G BONE CEMENT : BONE CEMENT Back to Search Results
Model Number 5450-32-500
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Discomfort (2330); Fibrosis (3167); No Code Available (3191)
Event Date 12/05/2018
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

On (b)(6) 2018, the patient underwent a third right knee revision due to pain, arthrofibrosis, discomfort, decreased range of motion, scarring, and tibial loosening at the cement to implant interface. The surgeon noted a tibial stress fracture while removing the tibial tray. The fracture was corrected with a screw and cement. Two depuy cement were used during the first revision on (b)(6) 2016. Doi: (b)(6) 2016 ( 2 depuy cements ); (b)(6), 2018; dor: (b)(6) 2018; right knee.

 
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Brand NameDEPUY/CMW 2G
Type of DeviceBONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
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 Key9036496
MDR Text Key161381925
Report Number1818910-2019-104500
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5450-32-500
Device Catalogue Number545032500
Device LOT Number7957560
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/31/2014
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: 09/13/2019 Patient Sequence Number: 1
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