Model Number N/A |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Joint Dislocation (2374)
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Event Date 02/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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Medical product: blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3010653.Blunt tip screw, 4x46mm; catalog#: 47-2486-046-40; lot#: 3024714.Blunt tip screw, 4x60mm; catalog#: 47-2486-060-40; lot#: 3054546.Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3033538.The manufacturer received x-rays and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00126; 0009613350-2022-00127; 0009613350-2022-00129.
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Event Description
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It was reported that operation was performed with ann nail system.After 4 months from the initial, surgeon found a screw of the proximal screws was backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.Patient involvement.No further outcome.
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Manufacturer Narrative
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This follow-up report is being submitted to relay corrected information investigation results are now available.During the investigation it was concluded that the device previously submitted on this medwatch is not a contributing element for the reported event and therefore has been moved to concomitant device.Please remove 0009613350-2022- 00128 from your records.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00126-1, 3068920 0009613350-2022-00129-1, 0009613350-2022- 00216, 0009613350-2022-00217.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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Investigation results are now available.During the investigation it was concluded that the device previously submitted on this medwatch is not a contributing element for the reported event and therefore has been moved to concomitant device.Please remove 0009613350-2022- 00128 from your records.
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Search Alerts/Recalls
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