Model Number N/A |
Device Problems
Mechanical Problem (1384); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
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Patient Problems
Bone Fracture(s) (1870); Failure of Implant (1924)
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Event Date 05/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: oxf ph3 cementless fem sz xsm; item# 154912; lot# 7055221, oxf anat brg rt x-sm 4mm pma; item# 160791; lot# 7029590.Foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00249, 3002806535-2022-00252.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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Event Description
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It was reported that during an initial knee arthroplasty the bearing spun out and fell off to the posterior joint capsule side.The surgeon then decided to use a different system, and the femur and tibia components were removed.During removal, the patient¿s femur bone cracked.Surgery was delayed for about 40 minutes.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D10: medical devices: oxf ph3 cementless fem sz xsm; item# 154912; lot# 7055221, oxf anat brg rt x-sm 4mm pma; item# 160791; lot# 7029590, trl brg w/slots xsm 4mm; item# 32-422694; lot# zb130301.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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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.The tibial component was not returned or pictures provided; visual and dimensional evaluations could not be performed on those components.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Medical records were not provided.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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Search Alerts/Recalls
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