Model Number N/A |
Device Problems
Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001)
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Patient Problems
Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
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Event Date 09/27/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D6a - oct 2018.D10 - medical product: catalog #: 11-210064, explor 9x30mm impl stem w/scr, lot # 029270.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02439 h3 other text : not returned.
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Event Description
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It was reported that a patient had an initial left elbow radial head replacement approximately 5 years ago.Subsequently, they were revised about a month ago due to disassociation.During the revision the head and screw stripped and flattened and there was metallosis throughout the joint.The head and screw were exchanged with an unknown component.The stem remains implanted.Attempts have been made and there is no further information at this time.
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Manufacturer Narrative
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(b)(4).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 further reported that the patient was experiencing pain and loss of range of motion due to the disassociation.
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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 and corrected information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02439-2.H6: component codes: mechanical (g04) - head.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right radial head replacement with disassociation of the head and screw from the stem as well as possible metallosis within the joint space.A definitive root cause cannot 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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Search Alerts/Recalls
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