Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 12/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Dob : unknown month and day in 1957.Concomitant medical products: catalog#: 010000821g7 hi-wall arcomxl lnr 36mm h lot#: 6621357.Catalog#: 110010269 g7 osseoti multihole 62mm h lot#: 6470239.Foreign report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: -0001825034-2020-04393.-0001825034-2020-04395.
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Event Description
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It was reported that during a revision surgery, there were made several attempts to seat a 36mm hi-wall liner with non-satisfactorily result.Another 32mm hi-wall liner was opened but this would not seat either.There was applied a 90 degrees impact with a mallet and several hard blows was attempted at each try.During the attempts to seat the liner, the patient sustained an acetabular fracture that was treated conservatively.Surgery was completed with a tmt modular cup and a 10 degree liner.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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The event was confirmed with product received.Visual inspection found pitting on the outer radius of the liner.The outer radius and sidewall are also scratched.The scallop at the end of the elevated portion of the liner is damaged.Device history record was reviewed and no discrepancies relevant to the reported event were found.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 further event information available at the time of this report.
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Search Alerts/Recalls
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