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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 Problem Loss of or Failure to Bond (1068)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577)
Event Date 06/17/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. 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 medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Primary operative notes (b)(6) 2017 indicate the patient received a left total knee replacement due to end stage osteoarthritis. The patella was resurfaced, and depuy cement was utilized x2. The surgery was completed without indication of complication by the surgeon. Revision operative notes (b)(6) 2019 indicate the patient received a left total knee revision due to functional restrictions, restricted range of motion, trace laxity, trace effusion, pain and discomfort with aseptic loosening of the tibial component. Upon entering joint, polywear was present on the insert. Scratching was present on the tibial component. The tibial component was noted to be loose and the cement to implant interface. The patella component was noted to be overstuffed. There was no indication of deficiency with the femoral component. All implants were removed. Competitor products were placed. The surgery was completed without indication of complication by the surgeon.

 
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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 dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11665175
MDR Text Key245411245
Report Number1818910-2021-07915
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)Y
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
Report Date 03/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2018
Device MODEL Number5450-50-501
Device Catalogue Number545050501
Device LOT Number8378516
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 Received05/27/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/30/2016
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: 04/14/2021 Patient Sequence Number: 1
Treatment
ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS FEM LT SZ 7 CEM; ATTUNE PS RP INSRT SZ7 6MM; ATTUNE RP TIB BASE SZ 7 CEM; DEPUY CMW 2 20G; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
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