Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 UNK ATTUNE KNEE TIBIAL TRAY
  • 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 UNK ATTUNE KNEE TIBIAL TRAY Back to Search Results
Catalog Number UNK ATTUNE KNEE TIBIAL TRAY
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189)
Event Date 06/08/2020
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 patient has a left total attune knee done by the surgeon and it is unknown when the knee was done.The patient was revised to address poor motion and pain.The surgeon revised the femur, and tibial tray.The femur was well fixed, and had cement stuck to its backside.The tibial tray popped out fairly easily, and had no cement stuck to its backside.The patella was well fixed and retained.The femur was prepped with attune revision instruments.A stem and sleeve were used.A surgical delay of 20 seconds was noted.Doi: unknown.Dor: (b)(6) 2020 left knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNK ATTUNE KNEE TIBIAL TRAY
Type of Device
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10173674
MDR Text Key195729300
Report Number1818910-2020-14128
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK ATTUNE KNEE TIBIAL TRAY
Was Device Available for Evaluation? No
Date Manufacturer Received07/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE CRS FEMORAL LT SZ 4 CEM; ATTUNE POS FEM AUG SZ 4 4MM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL INSERT; ATTUNE CRS FEMORAL LT SZ 4 CEM; ATTUNE POS FEM AUG SZ 4 4MM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL INSERT
Patient Outcome(s) Required Intervention;
Patient Age49 YR
-
-