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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET GMV 40G US EO BONE CEMENT : BONE CEMENT

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DEPUY ORTHOPAEDICS INC US 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 Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032)
Event Date 08/07/2019
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) 2016 indicate the patient received a left total knee replacement due to severe degenerative joint disease and flexion contracture. 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 pain, decreased range of motion. Initially, manipulation under anesthesia and joint aspiration was performed that provided temporary relief, it was then determined a revision was needed. Upon entering the joint, significant scar tissue was encountered and removed. The femoral and patella components were not revised, no indication of deficiency. The tibial component was subsided and loose at the cement to implant interface. Tibial insert revised without indication of deficiency. The surgery was completed without indication of complication by the surgeon. Doi: (b)(6) 2016. Dor: (b)(6) 2019; left knee.

 
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Brand NameSMARTSET GMV 40G US EO
Type of DeviceBONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
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 Key11738477
MDR Text Key247738068
Report Number1818910-2021-09057
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
Report Date 04/20/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2018
Device MODEL Number5450-50-501
Device Catalogue Number545050501
Device LOT Number8309492
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/04/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/28/2021 Patient Sequence Number: 1
Treatment
ATTUNE CR FB INSRT SZ 7 6MM; ATTUNE CR FEM LT SZ 7 CEM; ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE MEDIAL DOME PAT 41MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
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