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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 9 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY

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DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 9 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY Back to Search Results
Model Number 1506-00-009
Device Problems Loss of or Failure to Bond (1068); Migration (4003)
Patient Problems Pain (1994); Insufficient Information (4580)
Event Date 05/05/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
Clinical notification received for right knee revision to address migration and aseptic loosening of the tibial baseplate. Date of implantation: (b)(6) 2017. Date of revision: (b)(6) 2021; (right knee). Treatment: revision of tibial baseplate and insert.
 
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Brand NameATTUNE FB TIB BASE SZ 9 CEM
Type of DeviceATTUNE IMPLANT : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12061319
MDR Text Key258161062
Report Number1818910-2021-13528
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101433
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,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1506-00-009
Device Catalogue Number150600009
Device Lot Number8451723
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 Received08/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2017
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: 06/24/2021 Patient Sequence Number: 1
Treatment
ATTUNE CR FB INSRT SZ 9 7MM; ATTUNE CR FEM RT SZ 9 CEM; ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE MEDIAL DOME PAT 41MM; COMPETITOR BONE CEMENT (STRYKER); COMPETITOR BONE CEMENT (STRYKER)
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