ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM; PROSTHESIS, KNEE
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Model Number N/A |
Device Problems
Unstable (1667); Malposition of Device (2616)
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Patient Problems
Adhesion(s) (1695); Bacterial Infection (1735); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Deformity/ Disfigurement (2360); Joint Contracture (4528); Swelling/ Edema (4577)
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Event Date 12/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs ----------------------------------------------------- 42530008302 tibia trabecular metal two-peg porous fixed bearing rt size h lot# 64077392 mdr: 0001822565-2024-00496.42502806602 femur trabecular metal cruciate retaining (cr) std porous lot# 64317789 mdr: 0001822565-2024-00497.
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Event Description
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It was reported a patient reports pain, intermittent swelling, and deformity since surgery and then began experiencing instability, and a flexion contracture.Radiographic imaging displayed lucency of the femoral component and patellar button and 12 degrees varus alignment of the tibial component.Approximately one year post implantation the patient underwent a revision for instability and malalignment.All components, except the patella, were revised without complication.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs.----------------------------------------------------- 42530008302 tibia trabecular metal two-peg porous fixed bearing right size h lot# 64077392.Mdr: 0001822565-2024-00496.42502806602 femur trabecular metal cruciate retaining (cr) standard porous lot# 64317789.Mdr: 0001822565-2024-00497.42509902525 persona 2.5 mm female hex screw 25 mm length lot# 64591627.Mdr: 0001822565-2024-00949.
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Event Description
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It was reported a patient reports pain, intermittent swelling, and deformity since surgery and then began experiencing instability, and a flexion contracture.Radiographic imaging displayed lucency of the femoral component and patellar button and 12 degrees varus alignment of the tibial component.Approximately one year post implantation the patient underwent a revision for instability, arthrofibrosis, and malalignment.All components, except the patella, were revised without complication.During the surgery, cultures were taken and later, one of the cultures from the femoral membrane, grew evidence of propionibacterium acnes.The patient was placed on a three-month course of oral doxycycline.The patient has continued through the study without ongoing infection related complications.
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