Device Problems
Material Erosion (1214); Naturally Worn (2988)
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Patient Problems
Fatigue (1849); Pain (1994); Burning Sensation (2146); Dizziness (2194); Osteolysis (2377); Reaction (2414); Irritability (2421); Shaking/Tremors (2515); Sleep Dysfunction (2517); Cognitive Changes (2551)
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Event Date 04/30/2019 |
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 as the product remains implanted.The investigation is in process.Once the investigation is complete, a follow ¿up mdr will be submitted.Concomitant medical products: item# unknown/ unknown cup/ lot # unknown, item# unknown / unknown head/ lot # unknown, item# unknown/ unknown stem / lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -00924.0001825034 -2020 -00948.0001825034 -2020 -00921.
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Event Description
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It was reported patient underwent right hip surgery approximately 11 years ago patient has been indicated for a revision surgery due to pain, burning sensation, tenderness and elevated metal ion levels.Further, the patient is noted to have a metal allergy including cobalt.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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It was reported patient underwent right hip revision surgery approximately 10 years post implantation due to pain, burning sensation, tenderness and elevated metal ion levels.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.
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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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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 is unable to be determined as the necessary information to adequately investigate the reported event was not provided 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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Search Alerts/Recalls
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