Model Number N/A |
Device Problems
Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 06/29/2008 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Medical product: unknown taperlock stem, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00077.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.
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Event Description
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It was reported that a patient underwent an initial right hip arthroplasty on (b)(6) 2008.Subsequently, an orthopedic visit on (b)(6) 2009 revealed an anomalous distribution of load, causing significant pain in the lumbar area, and a further neurological examination made on (b)(6) 2010 confirmed the diagnosis.A claim for damages is made, allegedly caused by the adverse reaction to the metal ions (chromium and cobalt) released by the magnum cup and taperloc stem.Legal will not investigate the case, because the claim is time-barred.
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Event Description
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The patient's legal counsel reported that the patient underwent an initial right hip arthroplasty on (b)(6) 2008.Patient underwent an initial right hip arthroplasty on (b)(6) 2008.Subsequently, an orthopedic visit on (b)(6) 2009 revealed an anomalous distribution of load, causing significant pain in the lumbar area, and a further neurological examination made on (b)(6) 2010 confirmed the diagnosis.A claim for damages is made, allegedly caused by the adverse reaction to the metal ions (chromium and cobalt) released by the magnum cup and taperloc stem.Note: legal will not investigate the case, because the claim is time-barred.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.D11: medical product: unknown taperloc stem, catalog #: unknown, lot #: unknown multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00077-1.As the product has not been received, the investigation was limited to the information provided.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as item numbers and lot numbers are unknown.A review of the complaint database could not be performed as item numbers and lot numbers are unknown.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.
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Search Alerts/Recalls
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