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Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 07/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Cat#11-103206, taperloc por lat fmrl 12.5x145 and lot#656670.Cat#103532, ti low profile screw 6.5x25mm and lot#613380.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001825034-2019-01996 and 0001825034-2019-01997.
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Event Description
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It was reported a patient underwent initial left total hip arthroplasty approximately 19 years ago.Subsequently, the patient was revised approximately 3 years ago due to pain, elevated metal ions, and metallosis.During the revision, corrosion was found at the cup and liner.The stem was well-fixed and left intact.All other components were replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4, h2, h4, h6 medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: stress dose steroids and arixtra given due to history of hit (heparin-induced thrombocytopenia) presented with pain, elevated crp (30, normal <8), labs negative for infection, cobalt and chrome elevated with cobalt 4x the chromium, preoperatively diagnosed with altr creamy gray fluid encountered, no corrosion was seen at the head/neck junction stem stable and left intact 'the entire superior acetabulum and posterior wall was gone.The liner for the metal cup was removed and a significant amount of corrosion was seen at the liner/cup.' surgeon notes that metallosis was falsely elevating wbc count and does not feel this was an infection but wanted to proceed with caution and treat with iv antibiotics for 6-8 weeks prophylactically stem remained intact, head and sleeve replaced with biomet, acetabular components replaced with competitive components, no complications a review of the device history records identified deviations or anomalies during manufacturing, however, the deviations or anomalies would not have attributed to the event 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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