Model Number N/A |
Device Problem
Corroded (1131)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Metal Related Pathology (4530)
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Event Date 12/02/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Item# unknown liner lot# unknown.Item# unknown stem lot# unknown.Item# 00801803201 femoral head lot# 60975943.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 -2019 -00899.
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Event Description
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It was reported that patient underwent total hip arthroplasty on unknown date.Patient was revised due to alval/corrosion/pain.No further information available.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h2, h3, h6 reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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.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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Event Description
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It was reported the patient underwent left total hip arthroplasty.Subsequently revision was performed approximately 11 years later due to pain, elevated metal ions and corrosion.Femoral head was revised.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.D10: cat# 00620205422 shell porous with cluster holes 54 mm lot#60961728.Cat# 00631005032 liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells lot#60866550.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a healthcare professional.Patient was revised due to pain, elevated metal ions and corrosion.Labs taken before revision identified elevated cobalt levels along with normal sed rate and crp.During revision, capsule was thickened but not to degree that would expect with altr.There was staining of the trunnion that was cleaned.Tan staining to liner however decided to retain.Femoral head was exchanged.No other complications noted.Review of the device history records identified no deviations or anomalies during manufacturing.Additional information provided does not change the root cause of the previous investigation.A definitive root cause cannot be determined.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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