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Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Fall (1848); Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2024-00429, 0001822565-2024-00430, 0001822565-2024-00431, 0001822565-2024-00432.D10-medical product: unknown 14mm articular surface, unknown persona size e tibial tray, unknown 5mm half tibial augment block, unknown 12mm uncemented stem, unknown bone cement.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that a patient is experiencing pain, stiffness, instability, swelling, range of motion issues, and difficulty ambulating approximately five months post revision.Five months post op the patient began to feel like the knee was moving out of place which was followed by a fall a month later.The patient continued to have complications with pain, stiffness, difficulty walking, weakness, effusions, limited range of motion, and recurrent falls.The patient went through an additional series of physical therapy.There were no significant findings on radiographic imaging, and the patient was thought to have regional pain syndrome and referred to her pain management physician for appropriate treatment.No completed or planned surgical intervention has been reported at this time.There is no additional information available.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: feels knee moving out "out of place", several falls, stiffness, severe pain, difficulty walking, weakness, rom impairments, swelling.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.The complaint is confirmed via medical records.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: - mechanical (g04) - femur.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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