DEPUY ORTHOPAEDICS, INC. US 1818910 PINNACLE SECTOR II CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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Catalog Number 121722048 |
Device Problems
Disconnection (1171); Naturally Worn (2988); Noise, Audible (3273)
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Patient Problems
Pain (1994); Injury (2348); Not Applicable (3189)
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Event Date 07/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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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Event Description
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Revision right total hip joint replacement for 'failed' primary components as patient presented with pain, and described a clunk plus squeaking and grating noises, of which patient claims was over 18 months in duration.Patient was seen in clinic on the (b)(6) 2018.According to surgeon, the patient had obvious radiological evidence and clinical presentation to determine revision surgery required.Uncertain of why there was a delay between when the surgeon notified to the date of surgery.Surgeon performed a routine posterior approach in order to explant the affected implants, of which was the acetabular components only.The patient has a corail stem in-situ of which was well fixed and non-affected.All implants that were explanted were collected as best possible and are available for further review.
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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: examination of the acetabular cup does find evidence to support the reported disassociation event.Product error / contribution to the event is not identified.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: null.Device history batch: null.Device history review: null.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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Search Alerts/Recalls
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