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Model Number N/A |
Device Problem
Difficult or Delayed Separation (4044)
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Patient Problems
Local Reaction (2035); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign report source: (b)(6).Source: the journal of arthroplasty long term performance of an uncemented, proximally hydroxyapatite coated, double tapered, titanium-alloy femoral stem: results from 1465 hips at 10 years minimum ( jamie t griffiths, mbbs, bsc (hons), frcs (tr & orth) ) multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03070.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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 in a journal article that six patients underwent revision of the stem due to cold welded head.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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It was reported in a journal article that six patients underwent revision due to armd and cold welded head.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information. the following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.The additional information provided does not change the summary of previous investigation 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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