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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-105
Device Problem Use of Device Problem (1670)
Patient Problem Adhesion(s) (1695)
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
Medical records received (b)(6) 2018. Records indicate patient received an attune tka. No allegations provided of patient injury or product failure, nor report of revision. The patient underwent a left total knee arthroplasty on (b)(6) 2015 utilizing depuy synthes components including patella resurfacing with a competitor cement with no complications. On (b)(6) 2016, she underwent a revision for aseptic failure of the left tka. Intraoperatively, extensive scarring was found. The surgeon required osteotomes to remove the femoral and tibial components and any indication of loosening was never stated. The surgeon states that 6 degrees of external rotation from the previous external rotation was cut to "improve the alignment of the femoral component. " no other complications identified. Doi:(b)(6) 2015 dor: unknown (left).
 
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Brand NameATTUNE PS FEM LT SZ 5 CEM
Type of DeviceATTUNE IMPLANT : KNEE FEMORAL
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12474134
MDR Text Key271467898
Report Number1818910-2021-20118
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 consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1504-10-105
Device Catalogue Number150410105
Device Lot Number7873609
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 Received09/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2014
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: 09/15/2021 Patient Sequence Number: 1
Treatment
ATTUNE MEDIAL DOME PAT 29MM; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE RP TIB BASE SZ 5 CEM; STRYKER BONE CEMENT; STRYKER BONE CEMENT
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