• 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 LT 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 LT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-106
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Inflammation (1932); Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). 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

It was reported that there is a complaint to report against a knee implant. The knee implant has problems. Medical records received. On (b)(6) 2018, the patient underwent a left knee revision to address, pain, inflammation, and synovitis. The tibial tray was loose at the cement to implant interface and the femoral component was loose at an unknown interface. There was extensive bone loss involving the tibia and femur. The tibial insert, tibial tray, and femoral component were revised. The patellar component was retained. The patient was revised with competitor implants. There were no indicated intra-operative complications.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameATTUNE PS FEM LT SZ 6 CEM
Type of DeviceATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11400312
MDR Text Key234302273
Report Number1818910-2021-04190
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 04/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1504-10-106
Device Catalogue Number150410106
Device LOT Number7773969
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 Received05/18/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/02/2013
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: 03/02/2021 Patient Sequence Number: 1
Treatment
ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 6 5MM; ATTUNE PS FEM LT SZ 6 CEM; STRYKER SIMPLEX BONE CEMENT
-
-