Model Number N/A |
Device Problem
Malposition of Device (2616)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).G2: australia.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: 0001825034-2023-02514.H3 other text : unknown.
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Event Description
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It was reported a patient underwent a shoulder arthroplasty approximately 2 weeks ago.Subsequently, the patient was revised due to incorrect alignment of implants.The baseplate was left in, but there was a size exchange of the other components.Attempts have been made and there is no further information at this time.
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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).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.H3 other text : discarded.
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Manufacturer Narrative
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(b)(4).H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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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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(b)(4).Updated: b4, b5, d2, g3, h1, h2, h3, h6, h10 mechanical (g04) - stem reported event was unable to be confirmed due to limited information received from the customer and x-rays are not dated.Radiographs identified the following: not submitted to mmi as the image is not dated.This is an early post-op x-ray given the presence of incisional staples, however it is not clear whether this was pre or post revision as the initial surgery had only occurred one day prior.Therefore it would be difficult to correlate to the allegation and would not enhance the investigation.Device history record was reviewed and no discrepancies relevant to the reported event were found.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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Search Alerts/Recalls
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