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 ATTUNE PS FB INSRT SZ 8 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 8 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 151640805
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 09/18/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Occupation: lawyer.(b)(4).
 
Event Description
Attune litigation record received.Litigation record alleges severe and persistent pain, discomfort, instability, difficulty ambulating, swelling and aseptic loosening tibial tray at the cement to implant interface.Unknown cement was used.Doi: (b)(6) 2016, dor: (b)(6) 2020, left knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
Event Description
On (b)(6) 2016, the patient had a primary left total knee arthroplasty to address degenerative joint disease.Depuy components, including depuy patella were used during this procedure.On (b)(6) 2017 the patient had an aspiration and injection in his left knee to address persistent pain, soreness, and swelling.On (b)(6) 2019, the patient had a revision of the arthroplasty to address failed left total knee revision with tibial loosening, no interface provided.Femoral component was noted to be well fixed.Medical records noted that prior to surgery the patient was experiencing pain and swelling.Depuy components, including depuy cement were used during this procedure.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Udi : (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).3500a h10 cross reference for (b)(4), this device was also subject of (b)(4), as the patient experienced adverse events on different days with the same device.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATTUNE PS FB INSRT SZ 8 5MM
Type of Device
ATTUNE IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10726904
MDR Text Key212760765
Report Number1818910-2020-23210
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
K111433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2018
Device Catalogue Number151640805
Device Lot Number391645
Was Device Available for Evaluation? No
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 8 CEM; SMARTSET MV 20G - EO; SMARTSET MV 40G - EO; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE TIBIAL TRAY; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE TIBIAL TRAY
Patient Outcome(s) Required Intervention;
Patient Age66 YR
-
-