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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Osteopenia/ Osteoporosis (2651); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: item #: unknown, unknown liner, lot #: unknown; item #: unknown, unknown stem, lot #: unknown; item #: unknown, unknown cup, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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: 0001822565 - 2020 - 03121, 0001822565 - 2020 - 03123, 0001822565 - 2020 - 03124.
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Event Description
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It was reported that patient underwent an initial left total hip arthroplasty and has now been indicated for a revision approximately 8 years post primary implantation.However, a revision has not been reported.The sales rep was inquiring about implant identification.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Updated: b1, b4, b5, d11, g4, h2, h3, h6.Correction: d1.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.Radiographs review identified the following : radiolucency along the proximal femoral component.Osteopenia was observed.No other findings related to the reported event were noted.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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Search Alerts/Recalls
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