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Catalog Number 136536320 |
Device Problems
Device Dislodged or Dislocated (2923); Noise, Audible (3273)
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Patient Problems
Pain (1994); Joint Dislocation (2374)
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Event Date 07/20/2012 |
Event Type
Injury
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Manufacturer Narrative
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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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On 27 jul 2017: email notification received.Patient was revised for unknown reason.Components revised were head and liner.It was also mentioned that a formal litigation letter was sent.Update nov 21, 2017: medical records received.It was reported that the patient was revised to address dislocation, rotational and compression pain and click sound during walking due to pinnacle hip implant.Updated part and lot information.This complaint was updated on: nov 21, 2017.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4) investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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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