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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT

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DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-20-705
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Contracture (4528)
Event Date 05/25/2021
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
It was reported that the surgeon stated patient's knee was contracted. Removed poly, debrided and replaced the poly. No loosening and no delay in surgery reported. Doi: (b)(6) 2020, dor: (b)(6) 2021, left knee.
 
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Brand NameATTUNE CR FB INSRT SZ 7 5MM
Type of DeviceATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
JTE RAYNHAM MFG SITE
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key11969102
MDR Text Key255366245
Report Number1818910-2021-12271
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
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1516-20-705
Device Catalogue Number151620705
Device Lot NumberJ31H96
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 Received07/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2019
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: 06/09/2021 Patient Sequence Number: 1
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