• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 6 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 1516-40-605
Device Problem Difficult to Insert (1316)
Patient Problem Insufficient Information (4580)
Event Date 02/01/2021
Event Type  malfunction  
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
Upon inserting the definitive ps attune insert, the poly wouldn't lock into the base plate properly. A new insert was opened, which locked into the base plate as per normal. No patient consequences.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameATTUNE PS 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 Key11337796
MDR Text Key232183661
Report Number1818910-2021-03141
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K111433
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
Report Date 01/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1516-40-605
Device Catalogue Number151640605
Device Lot NumberHU7697
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-