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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL TRAY
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DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL TRAY Back to Search Results
Catalog Number UNK ATTUNE KNEE TIBIAL TRAY
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Attune knee claim record received.Claim record alleges pain, discomfort, instability, difficulty ambulating, mental suffering and aseptic loosening of the tibial tray.Unknown cement was used.Doi: (b)(6) 2014, dor: planned, left 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 ATTUNE KNEE TIBIAL TRAY
Type of Device
UNK ATTUNE KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10224427
MDR Text Key197379614
Report Number1818910-2020-14937
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 consumer,other
Type of Report Initial,Followup
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK ATTUNE KNEE TIBIAL TRAY
Was Device Available for Evaluation? No
Date Manufacturer Received07/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY
Patient Outcome(s) Required Intervention;
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