Model Number N/A |
Device Problems
Unstable (1667); Naturally Worn (2988)
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Patient Problems
Failure of Implant (1924); Unspecified Infection (1930)
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Event Date 10/25/2021 |
Event Type
Injury
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Event Description
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It was reported patient underwent total hip arthroplasty on unknown date.Subsequently underwent revision of implants for instability/aseptic failure.The customer also indicates a 32 cartridge from the company bioball, a polyethylene insert and 4 screws but we can¿t determine where it came from.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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(b)(4).Concomitant medical products: unknown stem item/lot unknown.Unknown bone screws item/lot unknown.Report source: (b)(6).The device will not be returned for analysis location unknown; 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: 0001822565 -2021 -03371, 0001822565 -2021 -03372.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D6a: implanted on unknown date in 2021.D10: unknown competitors head - unknown part and lot.H6: remove health effect ¿ clinical code 1930 ¿ unspecified infection.Reported event was unable to be confirmed due to limited information provided by the customer.Device history record was unable to be reviewed as the lot number is unknown.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed 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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It was reported that patient underwent a hip revision after an unknown amount of time post implantation due to abnormal wear of the poly liner, instability and malpositioning of the devices.The liner, cup and competitors head were removed and replaced.Attempts have been made and the additional information on the reported event is unavailable at this time.
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Search Alerts/Recalls
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