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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL

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DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL Back to Search Results
Model Number 1504-10-206
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/10/2021
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 underwent primary bilateral total knee replacement on (b)(6) 2020 where attune ps rp components were utilized. Patient reported recovering well until they sustained a fall. At the time of the fall, the right knee was injured. A quads mechanism tear was experienced but was not initially diagnosed. Patient has presented with ongoing pain of the right knee. X rays indicate that the patella has lowered. On opening the knee, the tear was evident and the extensor mechanism appeared thin and loose. The knee was checked - all components were well fixed, but the knee was loose through the range of motion, the healthcare professional elected to upsize the poly bearing from a 7mm to a 10mm - gaining additional stability. The quads tear was repaired and augmented by utilizing a lars ligament.
 
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Brand NameATTUNE PS FEM RT SZ 6 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 Key12532463
MDR Text Key273322884
Report Number1818910-2021-21149
Device Sequence Number1
Product Code OIY
UDI-Device Identifier10603295041771
UDI-Public10603295041771
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1504-10-206
Device Catalogue Number150410206
Device Lot Number9292157
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2021
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: 09/27/2021 Patient Sequence Number: 1
Treatment
ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FEM LT SZ 6 CEM; ATTUNE PS RP INSRT SZ 6 7MM; ATTUNE RP TIB BASE SZ 5 CEM; UNK CEMENT GENTAMICIN
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