DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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Model Number 52-3418 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 09/15/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that patient was implanted with metal on metal construct.Surgeon was unsure of original implant date.Patient was dealing with metallosis and the surgeon felt the patient would benefit from a head and liner exchange.Once dislocated, surgeon checked the stem and felt the trunnion was worn and the stem needed to be changed.Also, the patient had a lower spine fusion, so he felt the patient would benefit from a dual mobility construct.A new stem was implanted and the dm was trialed.The appropriate head size was selected and the real implant was opened and inserted.Hip was stable and the closing process began.Doi: unknown; dor: (b)(6) 2022; affected side: right.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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