Model Number N/A |
Device Problem
Corroded (1131)
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Patient Problem
Erythema (1840)
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Event Date 07/04/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: distal lateral fibular plate left 6 holes 106 mm length catalog 47235701806 lot 63782001; 3.5 mm cortical screw self-tapping 14 mm length catalog 00483501401 lot 63640159; 3.5 mm locking screw with 2.7 mm head 14 mm length catalog 00483501401 lot 63594075; 2.7 mm locking screw 18 mm length catalog 00483501401 lot 63861772; 2.7 mm locking screw 16 mm length catalog 00483501401 lot 63869781; 3.5 mm locking screw with 2.7 mm head 14 mm length catalog 00483501401 lot 63610822; 3.5 mm cortical screw 20 mm length catalog 00483501401 lot 62414571; 2.7 mm locking screw 18 mm length catalog 00483501401 lot 63861772; 2.7 mm locking screw 12 mm length catalog 00483501401 lot 62348895.Report source: foreign ¿ (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: 0001822565-2019-00724, 0001822565-2019-02485.
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Event Description
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It was reported that a plate was removed approximately four months post implantation after an erythema developed on the patient¿s leg.Corrosion was noted on implant.No additional information is available.
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Event Description
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No further information available at the time of this reporting.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A batch examination of devices with related issues was performed.Following the removal of contamination on the devices, scanning electron microscopy identified isolated pitting corrosion at the screw plate interface constrained to the locking threads of the plate and the screws.The isolated pitting was not identified in other locations of the locking plates and screws, including the discolored areas surrounding the holes from which the tissue deposits were removed.Review of device history records did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event.The analysis confirms the device and it¿s materials are conforming to specifications.Root cause is unable to be determined at this time.The device labeling states that in-vivo implant corrosion is a possible adverse effect that may be anticipated as the device is implanted in a corrosive environment.Occurrence rates are within the expected rates therefore; no further action is needed at this time.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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Search Alerts/Recalls
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