Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Muscular Rigidity (1968); Pain (1994); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 07052 ; 0001825034 - 2018 - 07059; patient not yet revised.
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Event Description
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It was reported that a patient underwent an initial shoulder arthroplasty on an unknown date.Subsequently, the patient has now been indicated for revision surgery due to unknown reasons.A custom glenoid has been requested.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 a patient underwent an initial shoulder arthroplasty on an unknown date.Subsequently, the patient has now been indicated for revision surgery due to pain and stiffness.A custom glenoid has been requested.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).
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Search Alerts/Recalls
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