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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE FEMORAL; KNEE FEMORAL
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DEPUY IRELAND - 9616671 UNK ATTUNE FEMORAL; KNEE FEMORAL Back to Search Results
Catalog Number UNK ATTUNE FEMORAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/21/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).(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 mcl rupture.A revision to a hinge construct was done.Doi: unknown.Dor: (b)(6) 2021.Unknown affected side.
 
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.Device history lot : a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.
 
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Brand Name
UNK ATTUNE FEMORAL
Type of Device
KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11949465
MDR Text Key254635054
Report Number1818910-2021-11990
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 05/21/2021
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? No
Device Operator Health Professional
Device Catalogue NumberUNK ATTUNE FEMORAL
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/21/2021
Initial Date FDA Received06/07/2021
Supplement Dates Manufacturer Received06/17/2021
Supplement Dates FDA Received06/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE CEMENTLESS STEM; ATTUNE CRS FEMORAL COMPONENT; ATTUNE SLEEVE; UNK ATTUNE KNEE TIBIAL INSERT; ATTUNE CEMENTLESS STEM; ATTUNE CRS FEMORAL COMPONENT; ATTUNE SLEEVE; UNK ATTUNE KNEE TIBIAL INSERT
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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