BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 4 PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED
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Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)
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Event Date 04/17/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: oxf twin-peg cmntd fem sm pma; ref# (b)(4); lot#684620.Oxf uni tib tray sza rm; ref# (b)(4); lot#702920.Cobalt g-hv bone cement 40g; ref# (b)(4); lot#783880.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00336 3002806535 - 2023 - 00337.
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Event Description
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It was reported that the patient had swelling, and a loose knee confirmed by x-rays.The patient experiences a hard time walking and ices to help reduce the pain and swelling.The patient had bloodwork to rule out possible infection and was prescribed medication to help with the swelling, pain, and muscle spasms.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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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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