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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 4 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT

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DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 4 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-40-405
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Laxity (4526)
Event Date 11/02/2021
Event Type  Injury  
Event Description
The patient was revised due to instability and loosening of the tibial tray at the cement to implant interface. Cement manufacturer is unknown. Doi: unknown. Dor: (b)(6) 2021. Left knee.
 
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.
 
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Brand NameATTUNE PS FB INSRT SZ 4 5MM
Type of DeviceATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12848498
MDR Text Key281134478
Report Number1818910-2021-25770
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1516-40-405
Device Catalogue Number151640405
Device Lot NumberC67355
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2016
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: 11/19/2021 Patient Sequence Number: 1
Treatment
ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE PS FB INSRT SZ 4 5MM; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN)
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