Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical product: femur cemented cruciate retaining (cr) catalog # 42502006001 lot # 64937118.Tibia cemented 5 degree stemmed catalog # 42532006401 lot # 64851317.All poly patella catalog # 42540000029 lot # 64890003.Biomet bc r 1x40 us catalog # 110035368 lot # f2701z34ca.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2023-00052, 3007963827-2023-00054, 0002648920-2023-00051.Remains implanted.
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Event Description
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It was reported patient is experiencing pain, swelling, damaged nerve and range of motion post implantation.Attempts to obtain additional information have been made; however, no more is available.
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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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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates discharge summary, noted weakness in peroneal and tibial distributions after spinal wore off along with reduced sensations in both distributions.Appears most consistent with a sciatic type of nerve palsy, unclear etiology but potentially due to post-spinal effect.Noted to be improving by pod 2 exam.Patient reported burning pain in foot bottom, knee swelling and pain, limited rom, tissue fused to device.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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