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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE FEMORAL
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DEPUY IRELAND - 9616671 UNK ATTUNE FEMORAL Back to Search Results
Catalog Number UNK ATTUNE FEMORAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
Event Date 06/08/2020
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
It was reported that the patient has a left total attune knee done by the surgeon and it is unknown when the knee was done.The patient was revised to address poor motion and pain.The surgeon revised the femur, and tibial tray.The femur was well fixed, and had cement stuck to its backside.The tibial tray popped out fairly easily, and had no cement stuck to its backside.The patella was well fixed and retained.The femur was prepped with attune revision instruments.A stem and sleeve were used.A surgical delay of 20 seconds was noted.Doi: unknown.Dor: (b)(6) 2020; left knee.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
UNK ATTUNE FEMORAL
Type of Device
ATTUNE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10173671
MDR Text Key195728731
Report Number1818910-2020-14129
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK ATTUNE FEMORAL
Was Device Available for Evaluation? No
Date Manufacturer Received07/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE CRS FEMORAL LT SZ 4 CEM; ATTUNE POS FEM AUG SZ 4 4MM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY; ATTUNE CRS FEMORAL LT SZ 4 CEM; ATTUNE POS FEM AUG SZ 4 4MM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY
Patient Outcome(s) Required Intervention;
Patient Age49 YR
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