Model Number N/A |
Device Problem
Use of Device Problem (1670)
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Patient Problems
Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)
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Event Date 09/07/2023 |
Event Type
Injury
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Event Description
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It was reported that the tibial cementless base plate is larger than the actual dimensions indicated on the label, and the cementless base plate with a larger dimension than indicated may have been used, resulting in a series of tibial fractures.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).D6 - product remains implanted.D10 - medical devices: oxf anat brg rt sm size 6 pma; item# 159571; lot# 7243251, oxford uni twin-peg femoral sm cocr sml; item# 166941; lot# j7445667.G2 - foreign: japan.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.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The product remains implanted; therefore, visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Radiographs were provided and reviewed by a radiologist.The review identified initial anatomic alignment of the right knee medial unicompartmental arthroplasty complicated by a periprosthetic fracture of the medial tibia with implant loosening and subsidence.Osteopenia.Initial fit and alignment were maintained.2 month imaging demonstrates tibial implant loosening and subsidence with malalignment secondary to a tibial periprosthetic fracture.Bone quality is osteopenic.The tibial implant is loose with subsidence and malalignment secondary to the periprosthetic fracture as noted.There is a medial tibial periprosthetic fracture.The degree of osteopenia present could contribute to a fracture in this patient.With the available information, a definitive root cause could not be determined however, osteopenia could be a contributing factor.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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