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 FEM LT SZ 3 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 IRELAND - 9616671 ATTUNE PS FEM LT SZ 3 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-123
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/28/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
The patient's knee was revised to address loosening of the femoral and tibial component at the cement to implant interface.Depuy cement was used.Doi: (b)(6) 2016, dor: (b)(6) 2021, left knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATTUNE PS FEM LT SZ 3 NAR CEM
Common Device Name
ATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12196688
Report Number1818910-2021-15522
Device Sequence Number14312997
Product Code OIY
UDI-Device Identifier10603295041689
UDI-Public10603295041689
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1504-10-123
Device Catalogue Number150410123
Device Lot Number721945
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/28/2021
Supplement Date Received by Manufacturer08/26/2021
Initial Report FDA Received Date07/20/2021
Supplement Report FDA Received Date08/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ATTUNE CR FEM LT SZ 3 NAR CEM; ATTUNE PS RP INSRT SZ3 5MM; ATTUNE RP TIB BASE SZ 3 CEM; SMARTSET HV BONE CEMENT 40G; ATTUNE CR FEM LT SZ 3 NAR CEM; ATTUNE PS RP INSRT SZ3 5MM; ATTUNE RP TIB BASE SZ 3 CEM; SMARTSET HV BONE CEMENT 40G
Outcome Attributed to Adverse Event Required Intervention;
Patient Age48 YR
-
-