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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 Pain (1994); Impaired Healing (2378); Joint Laxity (4526)
Event Date 11/30/2020
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
Patient initiated complaint received: it was reported that patient had an attune knee replacement and can¿t get knee to heal and surgery still not heal. Follow up conducted with further information provided: further information on (b)(6) 2021. Patient states she originally had both knees replaced 20 years ago with parts of an unknown manufacturer. She was revised to depuy components due to loosening of the unknown manufacturer's parts. She had her left knee revised to depuy components on (b)(6) 2019 and the right revised to depuy components on (b)(6) 2019. Both knees have had significant pain and feels unstable. The left had an arthroscopy done on (b)(6) 2020 with no improvement. She has had injections in both knees without improvement in pain. Her xrays are "clear. " she is planning to visit her surgeon this week to discuss another revision due to the pain.
 
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Brand NameATTUNE MEDIAL DOME PAT 38MM
Type of DeviceATTUNE IMPLANT : KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
CORK MFG & MATERIAL WAREHOUSE
loughbeg ringaskiddy
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key11664225
MDR Text Key245370010
Report Number1818910-2021-07868
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1518-20-038
Device Catalogue Number151820038
Device Lot Number9307880
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/14/2021 Patient Sequence Number: 1
Treatment
ATTUNE CRS FEMORAL LT SZ 5 CEM; ATTUNE CRS RP INSRT SZ 5 12MM; ATUN PRESSFIT STR STEM12X110MM; ATUN TIB SLV M/L 37MM HALF POR; ATUNE REV RP TIB BASE SZ 5 CEM; SMARTSET GMV 40G US EO
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