EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
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Model Number LOGIC TIBIA PS MOD INSRT TRIAL SZ 2.5 9MM |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Loss of Range of Motion (2032)
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Event Date 09/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Event Description
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It was reported that a 62 yo female patient, initial left knee implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2022, approximately 3 years 9 months post the initial procedure due to complaints of stiffness in their knee.During the procedure, the trial logic poly was removed using the logic style poly handle and once removed it was shown that the poly trial had broken on the underside.The surgeon used a rongure to remove the broken poly trial piece from the tibial tray and wound.The knee joint and surrounding wound was irrigated well.The new 9mm ps poly implant for the sz 2.5 was implanted into the knee and a final rom was performed.The surgeon was satisfied.There was a surgical delay while removing the parts and pieces from the wound site with no adverse event to the patient.The patient left the or stable.The device is available for return.The revision procedure is reported under report #1038671-2022-01327.
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Manufacturer Narrative
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After review of additional information received the following sections, have been updated accordingly: h6: based on historical complaint investigations, the returned device, and the reported event, the fractured logic ps tibial insert trial reported may have been the result of years of surgical use, aggressive use, and subsequent sterilization cycles which led to crack initiation, propagation, and ultimate fracture of the device during trialing.
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