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Catalog Number UNK-HIP |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Event Description
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New etq record created in order to update etq (legacy system) complaint number wpc (b)(4).Reason for original complaint ¿ litigation papers allege the patient was injured by excessive levels of chromium and cobalt.Update: plaintiff fact sheet received with part/lot information.No new information was received that would change the investigational results.Update rec¿d 6/25/2014 - sales rep reported revision surgery.Patient was revised to address pain.The patient previously had a resurfacing head, which was revised on (b)(6) 2009.Information for the resurfacing head can be located on wpc (b)(4).There is no new additional information that would affect the investigation.This complaint was updated on: 07/17/14.Update rec¿d 11/18/2014 - medical records received.Upon revision, fluid, adverse local soft tissue reaction, and no bony ingrowth on the acetabular cup were noted.The stem and sleeve are being added to the complaint for elevated metal ion levels.The stem remained in situ.This complaint was updated on: 12/18/2014.
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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.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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