Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision procedure due to unknown reasons.There is no additional information available at the time of this report.
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Manufacturer Narrative
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(b)(4).D10: 00632005632 item name liner 20 degree elevated rim 32 mm i.D.For use with 56 mm o.D.Shell lot # 62773101, unknown stryker head.Multiple mdr reports were filed for this event, please see associated reports.The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified lock ring returned in the lock ring groove.Bio debris embedded in the outer spherical surface.Inner spherical surface and face shows nicks and gouges.No other damage was noted for the shell.Visual review of the returned liner confirms item and lot identification.Nicks and gouges are noted to the inner and outer spherical surfaces as well as the rim.Rim and polar boss show indentation and deformation damage.Burrs are found on the rim.Pierce damage is noted through the liner sphere.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.An adequate complaint history review cannot be performed as the complication, failure mode, and/or harm experienced by the user is unknown.Medical records were not provided for this revision.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.A definitive root cause cannot be identified.This complaint cannot be confirmed.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 additional event information to report at this time.
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Search Alerts/Recalls
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