Model Number N/A |
Device Problems
Unstable (1667); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)
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Patient Problems
Fall (1848); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)
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Event Date 09/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001822565 -014 -01100.The reported event could not be confirmed as the product was not returned, no visual and dimensional evaluations could not be performed.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Unable to perform a complaint history review based on the provided information.Root cause was unable to be determined as the information provided was limited.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.Not returned to manufacturer.
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Event Description
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It was reported the patient had pain, difficulty ambulating, feeling of implant migration, and numbness.No further information has been made available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D10: 00625006525 ¿ bone screw ¿ 60470093.00625006550 ¿ bone screw ¿ 60436495.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 patient is reporting severe pain, instability, decrease in activities in daily life, and a fall causing device to push on sciatic nerve resulting in leg numbness.There is reported metallosis causing psoriasis and surgeon notes defective based off x-rays, the head is not seated properly.The patient ultimately underwent a right hip revision approximately 14 years post implantation.Attempts have been made and no additional information is available at this time.
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Manufacturer Narrative
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H6: component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided for the head and stem.Root cause unchanged.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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