ARTHREX, INC. IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Code Available (3191)
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Event Date 04/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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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