• 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 FEM RT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL

  • 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 FEM RT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-206
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Pain (1994); Synovitis (2094); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Product complaint #: (b)(4). Initial reporter occupation: lawyer. (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

On (b)(6) 2013 the patient had a right total knee arthroplasty to address degenerative arthritis of the right knee. There were no complications noted during the surgery. On (b)(6) 2019, the patient had a revision right total knee arthroplasty to address pain and loosening. The right femoral component was noted to be grossly loose with no interface provided. The surgeon reported loosening of the tibial tray at the cement/implant interface. The patella was noted to be well-fixed. The patient¿s bone quality was noted to be poor. The surgeon observed extensive bone loss on the femoral side and severe synovitis. Doi: (b)(6) 2013 dor: (b)(6) 2019 (right knee).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameATTUNE PS FEM RT SZ 6 CEM
Type of DeviceATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
CORK MFG & MATERIAL WAREHOUSE
loughbeg ringaskiddy
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr
warsaw, IN 46581
6107428552
MDR Report Key11418197
MDR Text Key239576540
Report Number1818910-2021-04468
Device Sequence Number1
Product Code OIY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1504-10-206
Device Catalogue Number150410206
Device LOT Number3608433
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/10/2013
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: 03/04/2021 Patient Sequence Number: 1
-
-