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 ORTHOPAEDICS INC US ATTUNE PS FEM LT SZ 5 NAR 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 ORTHOPAEDICS INC US ATTUNE PS FEM LT SZ 5 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-125
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Adhesion(s) (1695); Pain (1994); Not Applicable (3189); No Code Available (3191)
Event Date 05/10/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Doctor claimed the femoral and tibial components were loose.They were then extracted from the patient.Patient consequence? :unknown.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
 
Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Medical records received were reviewed by a clinician to identify product issues and/or patient harms.Intraoperative fluoroscope imaging dated (b)(6) 2018 confirms placement of the left knee prosthesis.Blood and urine pathology reports dated (b)(6) 2018 confirm no infection present.
 
Manufacturer Narrative
Product complaint # (b)(4).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.  corrected: h6 (no code available (3191) is used to capture the device revision or replacement).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATTUNE PS FEM LT SZ 5 NAR CEM
Type of Device
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7573593
MDR Text Key110224149
Report Number1818910-2018-61493
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295041702
UDI-Public10603295041702
Combination Product (y/n)N
PMA/PMN Number
K111433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1504-10-125
Device Catalogue Number150410125
Device Lot Number8233864
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2018
Date Manufacturer Received08/18/2020
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Treatment
ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FB INSRT SZ 5 5MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
Patient Outcome(s) Required Intervention;
Patient Age62 YR
-
-