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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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ARTHREX, INC. IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4
Device Problem Device Slipped (1584)
Patient Problem No Code Available (3191)
Event Date 04/25/2018
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It was reported via patient legal representative that on (b)(6) 2016 the patient had undergone a right total knee replacement procedure.The patient was later diagnosed with failed right total knee arthroplasty secondary to loosening and the patient underwent a revision right total knee arthroplasty on (b)(6) 2018 at a different facility by a different surgeon.Although the diagnosis mentioned loosening, there was no mention in the revision op report noting that any loosening was found.The patient's medical records also note that the patient is morbidly obese (bmi 42+ pre and post surgery) which is contraindicated for this device.During the revision procedure the following arthrex implants were removed: ar-513-t4 tibial tray (lot 10057043), ar-516-6r femoral implant (lot 1578051), ar-5623-b410 bearing implant (lot 115571546) and ar-504-psc9 patella implant (lot 132581609).The revision procedure was completed using another manufacturer's products.
 
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Brand Name
IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key8001597
MDR Text Key124961902
Report Number1220246-2018-00712
Device Sequence Number1
Product Code MBH
UDI-Device Identifier00888867187870
UDI-Public00888867187870
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152252
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 10/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Model NumberIBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4
Device Catalogue NumberAR-513-T4
Device Lot Number10057043
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/27/2018
Initial Date FDA Received10/24/2018
Date Device Manufactured08/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age49 YR
Patient Weight112
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