Model Number 1218-87-354 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Synovitis (2094)
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Event Date 12/16/2022 |
Event Type
Injury
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Event Description
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Clinical notification received for revision due to infection.Date of implant: (b)(6) 2008.Date of revision: (b)(6) 2022.(left hip).Treatment: revision; head and liner were revised.
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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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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) will not be performed since mom systems are obsolete.
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Event Description
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On (b)(6)2008, patient received an uncemented left metal-on-metal total hip replacement with s-rom femur and pinnacle cup mom to address osteoarthritis.There were no reported complications.On (b)(6)2022, patient had both the right and the left total hips revised to address hematogenous sepsis, fluid collections in both hips, acute pain and synovitis of the left hip, and chronic adverse reaction to metal debris of the right hip.The left hip also presented with gross pus, but in this case the rotators and capsule were still intact, there was no evidence in the left hip of chronic adverse reaction to metal debris.Cup and stem were well-fixed, with good positions in both cases, so only the head and metal liner were exchanged for polyethylene liner and metal head.Hip was well irrigated and debrided for treatment of the infection.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, h6 (clinical and impact codes) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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