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Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Pain (1994); Osteopenia/ Osteoporosis (2651)
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Event Date 10/30/2009 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Source: italy concomitant medical products: catalog number:15-105052 lot number: 529970 brand name: m2a 1 pc shell 38mmx52mm, catalog number:7100100306 lot number: 2008090173 brand name: ppf ltz stem sz 06x160mm.Multiple mdr reports were filed for this event, please see associated reports 0001825034-2020-02381.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.
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Event Description
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It was reported that the patient experienced pain approximately 4 years post implantation but refused the proposed revision surgery.The patient underwent blood tests approximately 9 years post implantation which resulted in elevated metal ion level.Additional information on the reported event is unavailable at this time.
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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 updated: b4, b5, g4, g7, h1, h2, h10.
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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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