Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2022 |
Event Type
Injury
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Event Description
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It was reported that a patient was revised approximately one year and eight months post implantation due to disassociation of the hinge pin and locking cap on the segmental distal femur.No further information is available.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-00539.Concomitant medical products: articular surface with segmental hinge post size c 14 mm height: item# 00585003014, lot# 63673429; polyethylene insert xt size c: item# 00585001396, lot# 64741569.Report source- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-00539.Concomitant medical products: articular surface with segmental hinge post size c 14 mm height: item# 00585003014, lot# 63673429; polyethylene insert xt size c: item# 00585001396, lot# 64741569.Report source- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.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 was reported that a patient was revised approximately one year and eight months post implantation due to disassociation of the hinge pin and locking cap on the segmental distal femur.No further information is available.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.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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