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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE PATELLA
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DEPUY IRELAND - 9616671 UNK ATTUNE KNEE PATELLA Back to Search Results
Catalog Number UNK ATTUNE KNEE PATELLA
Device Problem Naturally Worn (2988)
Patient Problems Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/18/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (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
Revision of an attune revision construct.Doctor was able to keep the tibial components in place and implanted an srom hinged femur with an lps/attune revision bridging bearing.Having spoken with the surgeon, he said it was because of an mcl rupture, which caused instability.He extracted the femoral component, offset adapter and press fit stem.Plus the insert.
 
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Brand Name
UNK ATTUNE KNEE PATELLA
Type of Device
ATTUNE KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11163638
MDR Text Key226604246
Report Number1818910-2021-00959
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK ATTUNE KNEE PATELLA
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/18/2020
Initial Date FDA Received01/13/2021
Supplement Dates Manufacturer Received01/15/2021
Supplement Dates FDA Received01/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PALACOS R+G BONE CEMENT.; UNK KNEE FEMORAL ADAPTOR ATTUNE.; UNK KNEE FEMORAL ATTUNE REVISION.; UNK KNEE STEM ATTUNE REVISION.; UNK KNEE STEM ATTUNE REVISION.; UNK KNEE TIBIAL INSERT ATTUNE REVISION.; UNK KNEE TIBIAL SLEEVE ATTUNE REVISION.; UNK KNEE TIBIAL TRAY ATTUNE REVISION.; PALACOS R+G BONE CEMENT; UNK KNEE FEMORAL ADAPTOR ATTUNE; UNK KNEE FEMORAL ATTUNE REVISION; UNK KNEE STEM ATTUNE REVISION; UNK KNEE STEM ATTUNE REVISION; UNK KNEE TIBIAL INSERT ATTUNE REVISION; UNK KNEE TIBIAL SLEEVE ATTUNE REVISION; UNK KNEE TIBIAL TRAY ATTUNE REVISION
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