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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK KNEE TIBIAL TRAY ATTUNE REVISION
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DEPUY IRELAND - 9616671 UNK KNEE TIBIAL TRAY ATTUNE REVISION Back to Search Results
Catalog Number UNK TIBIAL TRAY ATTUNE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 10/09/2020
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
The patient was revised to address infection and loosening of the unknown component at the bone to cement interface.Antibiotic spacer was placed in.Attune revision construct was removed.Doi: (b)(6) 2020.Dor: (b)(6) 2020; right 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.
 
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Brand Name
UNK KNEE TIBIAL TRAY ATTUNE REVISION
Type of Device
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10716116
MDR Text Key212454526
Report Number1818910-2020-23028
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 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK TIBIAL TRAY ATTUNE
Was Device Available for Evaluation? No
Date Manufacturer Received10/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8 RIGHT ATTUNE CRS FEMUR; CRS RP POLY; FEMORAL PRESS FIT STEM; FEMORAL SLEEVE POROUS; PRESSFIT TIBIAL STEM; RP REVISION ATTUNE TIBIA; TIBIAL SLEEVE; UNK KNEE FEMORAL AUGMENT ATTUNE; UNK KNEE FEMORAL AUGMENT ATTUNE; UNK KNEE FEMORAL AUGMENT ATTUNE; UNK KNEE FEMORAL AUGMENT ATTUNE; 8 RIGHT ATTUNE CRS FEMUR; CRS RP POLY; FEMORAL PRESS FIT STEM; FEMORAL SLEEVE POROUS; PRESSFIT TIBIAL STEM; RP REVISION ATTUNE TIBIA; TIBIAL SLEEVE; UNK KNEE FEMORAL AUGMENT ATTUNE; UNK KNEE FEMORAL AUGMENT ATTUNE; UNK KNEE FEMORAL AUGMENT ATTUNE; UNK KNEE FEMORAL AUGMENT ATTUNE
Patient Age50 YR
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