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Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Hair Loss (1877); Hearing Impairment (1881); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Visual Disturbances (2140); Dizziness (2194); Metal Related Pathology (4530)
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Event Date 01/31/2023 |
Event Type
Injury
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Event Description
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It was reported that approximately 20 years post implantation of a left total hip arthroplasty, the patient was revised due to pain, systemic metal related pathology symptoms, and localized metallosis.The patient reportedly had elevated cobalt and chromium levels attributing to lightheadedness, dizziness, loss of balance, tinnitus, visual changes, hearing changes, memory loss, brittle nails and teeth, and hair loss.During the revision, trunnion corrosion was identified.The femoral head was replaced with a dual mobility construct without complications, and the initial cup and stem were retained.No additional information.
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Manufacturer Narrative
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(b)(4).D10: cat# rd118850, lot# 881660, m2a 38mmx50mm cup.Cat# 11-173661, lot# 000350, m2a head.Product will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00260 and 0001825034-2024-00259.
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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: b4;g3;h2;h3;h6 h6: component code: mechanical (g04) - stem no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues including lightheadedness, dizziness, loss of balance, tinnitus, visual changes, hearing changes, memory loss, brittle nails and teeth, hair loss, metallosis, elevated serum cobalt and chromium levels, and black corrosion found on the trunnion.The reported issue was confirmed via the provided medical records; however, it was determined that the stem did not cause or contribute to the reported 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 is available at the time of this report.
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Search Alerts/Recalls
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