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Model Number N/A |
Device Problem
Corroded (1131)
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Patient Problems
Pain (1994); Local Reaction (2035); Tissue Breakdown (2681); Swelling/ Edema (4577)
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Event Date 01/23/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 157446-m2a-magnum mod hd sz 46mm-217340.Us157852- m2a-magnum pf cup 52odx46id-768350.103200-taperloc por fmrl 5.0x130-005640.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09546, 0001825034-2018-09547, 0001825034-2018-10445.Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device showed scuffing on the outside diameter and visible debris inside of the taper.A review of the device history records identified no deviations or anomalies during manufacturing.Root cause of the event could not 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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It was reported that the patient underwent a revision approximately eight years post initial surgery due to pain, swelling, and elevated metal ions.During the revision surgery, the surgeon noted a large murky fluid collection and stained synovial tissue in the posterior capsule as well as clear trunnion corrosion and tissue damage.Attempts have been made and additional information on the reported event is unavailable at this time.
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Search Alerts/Recalls
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