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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL RT SZ 4 CEM; KNEE FEMORAL
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DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL RT SZ 4 CEM; KNEE FEMORAL Back to Search Results
Model Number 1504-40-204
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/10/2021
Event Type  Injury  
Manufacturer Narrative
(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
Patient was revised to treat infection and loosening of the femoral component at the cement to implant interface.Depuy cement was utilized.Patient received a temporary spacer.Doi: (b)(6) 2019, dor: (b)(6) 2021, unknown knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.
 
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Brand Name
ATTUNE CRS FEMORAL RT SZ 4 CEM
Type of Device
KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11838963
MDR Text Key251225228
Report Number1818910-2021-10506
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295042273
UDI-Public10603295042273
Combination Product (y/n)N
PMA/PMN Number
K160700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1504-40-204
Device Catalogue Number150440204
Device Lot NumberJ11C30
Was Device Available for Evaluation? No
Date Manufacturer Received07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL RT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 8MM; ATTUNE DIST FEM AUG SZ 4 4MM; ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE POS FEM AUG SZ 4 4MM; ATTUNE POS FEM AUG SZ 4 8MM; ATUNE REV RP TIB BASE SZ 5 CEM; SMARTSET GMV GENTAMICIN 40G; SMARTSET GMV GENTAMICIN 40G; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL RT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 8MM; ATTUNE DIST FEM AUG SZ 4 4MM; ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE POS FEM AUG SZ 4 4MM; ATTUNE POS FEM AUG SZ 4 8MM; ATUNE REV RP TIB BASE SZ 5 CEM; SMARTSET GMV GENTAMICIN 40G; SMARTSET GMV GENTAMICIN 40G
Patient Outcome(s) Required Intervention;
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