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Catalog Number UNKNOWN ALPS OLECRANON PLATE |
Device Problems
Fracture (1260); Unstable (1667); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Malunion of Bone (4529)
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Event Date 06/09/2020 |
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: 0001825034-2021-00616, 0001825034-2021-00617, 0001825034-2021-00618, 0001825034-2021-00619, 0001825034-2021-00620, 0001825034-2021-00621.Concomitant medical product: item#: unknown, unknown locking screw; item#: unknown; item#: unknown, unknown locking screw; lot #: unknown; item#: unknown, unknown locking screw; lot#: unknown; item#: unknown, unknown cortical screw; lot#: unknown; item#: unknown, unknown cortical screw ; lot#: unknown; item#: unknown, unknown cortical screw; lot#: unknown.Customer has not indicated whether the product will be returned to zimmer biomet for investigation at this time, product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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Event Description
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It was reported patient underwent a right elbow o.R.I.F approximately one (1) yr and four (4) months ago.Patient's elbow was revised on an unknown date due to implant failure.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00616-1, 0001825034-2021-00617-1, 0001825034-2021-00618-1, 0001825034-2021-00619-1, 0001825034-2021-00620-1, 0001825034-2021-00621-1.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial elbow surgery occurred.Elbow revised on an unknown date due to implant failure.A definitive root cause could not be determined.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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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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(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00616-3, 0001825034-2021-00617-3, 0001825034-2021-00618-3, 0001825034-2021-00619-3, 0001825034-2021-00620-3, 0001825034-2021-00621-3.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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Event Description
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It was reported that the patient underwent an initial right elbow o.R.I.F approximately one (1) year and six (6) months ago.The patient underwent a revision surgery approximately six (6) months after initial surgery due to pain, loosening, implant fracture, decrease of activity of daily living, non-union/malunion, and instability.
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Event Description
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It was reported that the patient underwent an initial right elbow o.R.I.F approximately one (1) year and six (6) months ago.The patient underwent a revision surgery approximately six (6) months after initial surgery due to pain, implant fracture and loosening.
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Manufacturer Narrative
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Cmp(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00616-2; 0001825034-2021-00617-2; 0001825034-2021-00618-2; 0001825034-2021-00619-2; 0001825034-2021-00620-2; 0001825034-2021-00621-2.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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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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(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00616-4, 0001825034-2021-00617-4, 0001825034-2021-00618-4, 0001825034-2021-00619-4, 0001825034-2021-00620-4, 0001825034-2021-00621-4.The additional information does not change root cause of previous investigation.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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