• 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 PATELLA

  • 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 PATELLA Back to Search Results
Catalog Number UNK ATTUNE KNEE PATELLA
Device Problems Use of Device Problem; Malposition of Device
Event Date 11/13/2019
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

The patient was revised due to patella maltracking. The doctor didn't put enough external rotation on the femur during the revision and are going back in to correct this problem so the patella tracks better. Doi: (b)(6) 2019. Dor: (b)(6) 2019. Left knee.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK ATTUNE KNEE PATELLA
Type of DeviceUNK ATTUNE KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-0988
6103142063
MDR Report Key9429671
Report Number1818910-2019-121492
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK ATTUNE KNEE PATELLA
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 Received01/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/06/2019 Patient Sequence Number: 1
Treatment
ATTUNE CRS RP INSRT SZ 9 10MM
ATTUNE POS FEM AUG SZ 9 12MM
ATTUNE POS FEM AUG SZ 9 8MM
ATUN FEM SLV M/L 35MM FULL POR
ATUNE PRESSFIT STR STEM18X60MM
-
-