Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Osteolysis (2377)
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Event Date 07/20/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01870.D10: unk g7 cup.Unk corail stem (competitor).G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.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 the patient underwent an initial hip procedure.Subsequently the patient was revised approximately 7 years later due to a large pseudotumor with bone loss primarily interior to cup.Attempts have been made and no further information has been provided.
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Event Description
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No further information 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 information.The following sections were {update/corrected}.Visual examination of the provided pictures identified the liner and head on a table.No image was provided for the retained cup.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records were provided but did not enhance the investigation.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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Search Alerts/Recalls
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