Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214); Noise, Audible (3273)
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Patient Problems
Failure of Implant (1924); Pain (1994); Synovitis (2094); Metal Related Pathology (4530)
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Event Date 01/19/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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: 0001825034-2022-01541.
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Event Description
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It was reported the patient underwent a left hip revision approximately 14 years post implantation due to pain, squeaking, and elevated chromium/cobalt levels.Attempts have been made and no further information has been provided.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) ¿ head.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient complains of shooting pain in l hip down into proximal femur.Patient reports hip has performed well regarding comfort/mobility until now with development of distracting squeaking.Cobalt and chromium levels returned elevated.Acetabular component was found to be stable with no burnishing or discoloration.Marked synovitis upon opening of posterior capsule, fluid evacuated and sent for culture.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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 additional event information to report at this time.
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Search Alerts/Recalls
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