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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 32MM ATTUNE IMPLANT : KNEE PATELLA

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DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 32MM ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-20-032
Device Problem Off-Label Use (1494)
Patient Problems Fall (1848); Fatigue (1849); Muscle/Tendon Damage (4532)
Event Date 09/26/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter 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
On (b)(6) 2019, the patient underwent a second left knee revision with an exchange of the competitor tibial insert and surgical intervention to correct an extensor mechanism failure with partial quad tendon tear and disruption of vmo. The patient was experiencing weakness and falls prior to revision. The surgeon noted surgical intervention involving the depuy patellar component, however, the patellar component was retained. Task initiated to create a new pc to capture second revision. Doi: (b)(6) 2016 (patella), doi: (b)(6) 2019 (competitor insert, femoral and tibial components captured in (b)(4)) dor: (b)(6) 2019.
 
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Brand NameATTUNE MEDIAL DOME PAT 32MM
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 Key11731564
MDR Text Key247488483
Report Number1818910-2021-08843
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model Number1518-20-032
Device Catalogue Number151820032
Device Lot Number8147361
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2015
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: 04/27/2021 Patient Sequence Number: 1
Treatment
STRYKER FEMORAL COMPONENT; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT; STRYKER STEM CEMENTED; STRYKER STEM CEMENTED; STRYKER TIBIAL BASEPLATE; STRYKER TIBIAL INSERT; SYNTHES SCREW; SYNTHES SCREW
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