Model Number N/A |
Device Problems
Material Erosion (1214); Compatibility Problem (2960)
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Patient Problems
Host-Tissue Reaction (1297); Necrosis (1971); Osteolysis (2377); Reaction (2414)
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Event Date 01/25/2017 |
Event Type
Injury
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Manufacturer Narrative
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Cmp-(b)(4).Concomitant medical products - m2a taper 37/28mm liner/ pn 15-105000/ l n393430, m2a-t m/h rad sld/apx shl 48mm/ pn 15-104048/ ln 830740, bi-metric cdh por n/c 11x134/ pn 162309/ ln 447730.Customer has indicated that the product will not be returned to zimmer biomet for investigation as its 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 report: 0001825034-2017-02542.
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Event Description
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It was reported by patient's legal counsel that patient had a right hip revision approximately 13 years post implantation due to rejection of metal on metal components.It was further reported that patient had large visible pseudotumors, osteolysis, and bony necrosis as well as metallosis and bone loss.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A 28mm m2a mod head -3mm nk, part # 11-163661 from lot 529580, was returned and evaluated against the complaint.The head is scuffed such that part of the finish has become hazy and dull.Scratching and dried debris were also observed on the head.A m2a taper 37/28mm liner, part # 15-105000 from lot 393430, was returned and evaluated against the complaint.The liner is assembled with the returned cup.The finish of the inner radius has become hazy and dull.Foreign debris was also observed on the inner radius.The liner is scratched.Additional information provided does not change the root cause of the 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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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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