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Catalog Number 11-163686 |
Device Problem
Material Erosion (1214)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Osteolysis (2377); Reaction (2414)
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Event Date 06/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown cup, pn unknown, ln unknown.Multiple mdr reports were filed for this event.Please see reports:0001825034-2018-08905.Customer has indicated that the product will not be returned to zimmer biomet for investigation (retained by hospital).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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It was reported that patient received the first total hip arthroplasty approximately 10 years prior to the revision surgery which was due to pain, severe osteolysis, larger pseudotumor, severely elevated cobalt and chromium levels.Attempts to obtain additional information have been made; however, no more is available.
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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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This follow-up report is being submitted to relay additional information.Concomitant medical products: pn:15-105044, m2a tpr hi carbon 41/32mm lnr ln: 075190, pn x11-180308, bi-metric/x por nc lat 8x120, ln 013230, pn 10-111154, c2a-t m/h rad 2hl shl 41/54mm, ln 555190.Complaint sample was evaluated and the reported event was not confirmed.Device history record (dhr) was reviewed and no discrepancies were found.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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Search Alerts/Recalls
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