ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM,COMP.ACET,UNC,44/38,CODE D; DUROM ACETABULAR COMPONENT
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Model Number N/A |
Device Problems
Patient Device Interaction Problem (4001); Migration (4003)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2022 |
Event Type
Injury
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Event Description
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It was reported that there was intrapelvic migration for severe debris disease.
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Manufacturer Narrative
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This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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).
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and corrected information.It was reported that there was an intrapelvic migration for severe debris disease in a 79-year-old patient.The device was discarded and no pictures were provided; therefore, visual evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Due to patient privacy regulations, neither patient nor medical data were provided.A definitive root cause cannot be determined.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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