Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214); Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); No Information (3190)
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Event Date 09/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical product(s): 00801803602 femoral head 61357236; 00875101336 liner neutral 36 mm 61303880; 00875705802 shell with multi holes 61321986; 00625006530 bone scr 61341911; 00625006535 bone scr 61341914.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.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: 0002648920 - 2020 - 00209 head.
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Event Description
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It was reported that the patient underwent left total hip arthroplasty and was later revised nine years later due to unknown reasons.The femoral head was exchanged.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(6).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records identified the following : patient underwent a revision procedure on due to elevated metal ions, pain, corrosion, and pseudotumor.Blood work showed that patient had elevated meta ions.Post revision blood work showed a reduction in the metal ion levels during the revision procedure, corrosion was noted at the head/ neck junction.Pseudotumor was observed in the joint space.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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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4) this follow-up report is being submitted to relay additional information.Updated: a1, a2, a6, b4, b5, b6, g4, h2, h3, h6 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 the patient underwent left total hip arthroplasty and was later revised nine years later due to left hip pain, elevated metal ions, corrosion and pseudotumor.Attempts have been made and no further information has been provided.
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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).This follow-up report is being submitted to relay additional information.Updated: a4, b4, b5, b7, g4, h2 corrected: e1 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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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.The received additional information does not change the final results of previous investigation.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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Search Alerts/Recalls
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