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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM; ATTUNE IMPLANT : KNEE PATELLA
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DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM; ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-20-038
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscular Rigidity (1968); Joint Laxity (4526)
Event Date 07/20/2021
Event Type  Injury  
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 left total knee replacement.Removal of attune revision implants, (tibial sleeve was not removed), due to stiffness, instability.There was no extended surgical time.Surgeon stated the femoral implant was oversized.No deficiency with the product.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary "no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE MEDIAL DOME PAT 38MM
Type of Device
ATTUNE IMPLANT : KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12277393
MDR Text Key265062042
Report Number1818910-2021-17049
Device Sequence Number1
Product Code OIY
UDI-Device Identifier10603295056690
UDI-Public10603295056690
Combination Product (y/n)N
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1518-20-038
Device Catalogue Number151820038
Device Lot Number9058703
Was Device Available for Evaluation? No
Date Manufacturer Received09/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE CRS FEMORAL LT SZ 5 CEM; ATTUNE CRS RP INSRT SZ 5 8MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 5 4MM; ATTUNE POS FEM AUG SZ 5 8MM; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; CEMENT MFG AND PRODUCT NAME UNKNOWN; ATTUNE CRS FEMORAL LT SZ 5 CEM; ATTUNE CRS RP INSRT SZ 5 8MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 5 4MM; ATTUNE POS FEM AUG SZ 5 8MM; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; CEMENT MFG AND PRODUCT NAME UNKNOWN
Patient Outcome(s) Required Intervention;
Patient Age79 YR
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