IBAL UKA TIB TRAY SZ 2,LFT-MEDIAL/RL AR-501-TTLB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for IBAL UKA TIB TRAY SZ 2,LFT-MEDIAL/RL AR-501-TTLB manufactured by Arthrex, Inc..

Event Text Entries

[127857975] 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.
Patient Sequence No: 1, Text Type: N, H10


[127857976] It was reported by the patient's legal representative that the patient had undergone a left knee menisectomy and chondroplasty on (b)(6) 2015. Thereafter, on (b)(6) 2015 the patient had a hemi-arthroplasty on her left knee. The records provided list that the following arthrex products were implanted during the (b)(6) 2015 procedure: ar-501-ttlb ibalance uni-tibial tray (lot 108761228), ar-501-uflc ibalance uni-femoral implant (lot 1470559) and ar-501-tbb0 ibalance uka tibial bearing (lot 77941142). On (b)(6) 2015 the patient underwent another surgery converting the uni-knee to a total knee replacement. According to the medical records the pre-op diagnosis, and x-ray findings prior to the (b)(6) 2015 procedure note a loose femoral component. However, the operative report notes that the tibial baseplate was loose, not the femoral component. During the procedure the hemi-arthroplasty implants were removed and the following left tka ibalance system components were implanted: ar-503-tttd tibial baseplate (lot 1297044), ar-517-4l femoral implant (lot 1438430), ar-503-a313 tibial bearing implant (13mm) (lot 113601414) and ar-504-psa8 patella implant (lot 113601322). Another manufacturer's bone cement was used with the arthrex implants. The medical records provided note that the patient? S bmi was (b)(6) which is a contraindication for both the uni and tka devices.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220246-2018-00761
MDR Report Key8086810
Date Received2018-11-19
Date of Report2018-11-19
Date of Event2015-11-06
Date Mfgr Received2018-10-24
Date Added to Maude2018-11-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactVIK BAJNATH
Manufacturer Phone8009337001
Manufacturer G1ARTHREX, INC.
Manufacturer Street1370 CREEKSIDE BOULEVARD
Manufacturer CityNAPLES FL 341081945
Manufacturer CountryUS
Manufacturer Postal Code341081945
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameIBAL UKA TIB TRAY SZ 2,LFT-MEDIAL/RL
Generic NamePROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Product CodeKRR
Date Received2018-11-19
Model NumberIBAL UKA TIB TRAY SZ 2,LFT-MEDIAL/RL
Catalog NumberAR-501-TTLB
Lot Number108761228
Device Expiration Date2017-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerARTHREX, INC.
Manufacturer Address1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-11-19

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