Model Number N/A |
Device Problems
Unstable (1667); Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 08/03/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: comp rvrs shdr glen bsplt +ha part # 115330 lot # 629650.Comp primary stem 8mm std part # 113648 lot # 985870.Comp rvrs shldr glnsp std 36mm part # 115310 lot # 239030.Arcom xl 44-36 std hmrl brng part # xl-115363 lot # 853780.Versa-dial/comp ti std taper pr adaptor part # 118001 lot # 362020.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 06871, 0001825034 - 2017 - 06872, 0001825034 - 2017 - 06874, 0001825034 - 2017 - 06875, 0001825034 - 2017 - 06876.It is unknown if the product will 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.
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Event Description
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It is reported that the patient received a comprehensive reverse shoulder 5 1/2 years ago.It has been further reported that the patient is being considered for a revision due to unknown reasons. attempts have been to find more information made but no more information is available at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.
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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 was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was 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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Event Description
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It is reported that the patient underwent revision surgery 5 1/2 years post initial surgery dur to instability.Attempts have been to find more information made but no more information is available at this time.
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Search Alerts/Recalls
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