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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 6 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT

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DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 6 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-20-605
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Fall (1848); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/21/2021
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
Patient had a fall post-op and loosening of tibial occurred. Radiolucent lines appeared in xrays, but no pain. Pain appeared at 1 year mark. Tibial revised. Insert change and patella revision due to scratch on prosthesis and bony spurs/scar tissue difficult to access, therefore got scratched. Appeared to be cement to bone interface that had broken down. Dor: (b)(6) 2021.
 
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Brand NameATTUNE CR FB INSRT SZ 6 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 Key12142868
MDR Text Key260710542
Report Number1818910-2021-14850
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K101433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1516-20-605
Device Catalogue Number151620605
Device Lot NumberHT0689
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 Received09/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2018
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: 07/09/2021 Patient Sequence Number: 1
Treatment
ATTUNE CR FB INSRT SZ 6 5MM; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM
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