EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 200-07-32 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/09/2020 |
Event Type
Injury
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Event Description
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As reported by the truilant knee clinical study, this 65 y/o obese female patient was experiencing patellar clunk syndrome, patient declined surgical intervention (arthroscopy) at this time.The case report form indicates this event is definitely related to devices and procedure.This event report was received through clinical data collection activities.No additional information.
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Manufacturer Narrative
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Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent condition cannot be conclusively determined; however, it may have been related to the patient condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.Patellar clunk is caused by a fibrous nodule of scar tissue at the posterior surface of the distal quadriceps tendon/superior patellar pole catching on the box of the femoral component during knee extension (patellar clunk syndrome (b)(6) 2021).Concomitant device(s): 02-020-11-0340 - truliant ps cem fem ps cem right sz 4, (b)(4), 02-022-35-4009 - truliant tib imp ps insert sz 4 9mm, (b)(4).Serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t, (b)(4).
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Manufacturer Narrative
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Section h11: the following sections have corrected information: (d1) brand name: truliant ps cem fem ps cem right sz 4, (d4) catalog number: 02-020-11-0340, serial number: (b)(6), expiration date: 06-sep-2027, unique identifier (udi) #: (b)(4).(d10) concomitant device(s): 02-022-35-4009 - truliant tib imp ps insert sz 4 9mm, s028289, serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t, 5789055, 200-07-32 - advanced patella 32mm 3 peg implant 6187770, (g4) pma/510(k)number: k170240, (h4) device manufacture date: 06-sep-2017.
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