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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Ambulation Difficulties (2544); Balance Problems (4401); 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 reports: 0001825034-2022-01642, 0001825034-2022-01643, and 0001825034-2022-01645.Medical devices: vanguard cr ilok fem-rt 62.5 catalog#: 183006 lot#: ni.Vngd cr lip tib brg 10x63/67 catalog#: 183520 lot#: ni.Bmet arcom ap pat w/wire 28mm catalog#: 11-150825 lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 patient underwent a right knee arthroplasty.Subsequently, patient has been experiencing pain, difficulty walking, unsteady balance, swelling, numbness, weakness, and difficulty to fully extend the implanted knee.No revision procedure has been reported.
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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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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Primary operative notes do not indicate any intra operative complications.Office notes state patient is experiencing moderate difficulty walking a mile, performing heavy activities around home and slight difficulty performing usual work, housework, and light activities.Patient reports pain, swelling, and difficulty walking, fatigue/weakness, stiffness, right lower extremity feels longer than left, numbness, stiffness, poor balance and inability to fully straighten leg.Rom 0-110; knee extension slightly limited at end of range of extension with arom.X-ray review by mmi states that anatomic alignment of the knee arthroplasty without acute abnormality or implant loosening.Bone quality appears osteopenic.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of complaint history for part#141212 identified no additional similar complaints for the reported item.However, as the lot number is unknown, an additional review could not be performed.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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