Model Number 1218-87-358 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Joint Dislocation (2374); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/26/2022 |
Event Type
Injury
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Event Description
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Patient was revised due to bilaterally metal on metal bearing bc of rising metal levels and possible psuedotumor seen on mri.The left side was revised first; head was dislodged without incident and then the metal liner was dislodged without incident.A hole eliminator, 36x58neutral poly liner, and 36+12 ceramic head were implanted.The right was revised second;head was dislodged without incident and then the metal liner was dislodged without incident.A hole eliminator, 36x58neutral poly liner, and 36+12 ceramic head were implanted.There was no surgical delay.Doi: unknown, dor: (b)(6) 2022, affected side: left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).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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Search Alerts/Recalls
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