Catalog Number 999890147 |
Device Problem
Noise, Audible (3273)
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Patient Problem
Pain (1994)
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Event Date 01/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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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.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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Reason(s) for revision: pain, noise.Update - alert date (b)(6) 2017.(b)(6) confirmed revision surgery took place on (b)(6) 2017.
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Manufacturer Narrative
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Asr revision due (b)(4) 2017.Asr xl left.Reason(s) for revision: pain, noiseupdate - alert date (b)(4) 2017.(b)(4) confirmed revision surgery took place on (b)(4) 2017.Amended event date and added date of revision - see attachment dated (b)(4) 2017.Ek (b)(4) 2017.Update alert date 25 jan 2017.Added lot number, manufacturing date and faclity for cup and head - lot numbers unavailable for stem and sleeve update aug 15, 2017: email notification from (b)(4) received.There is no new information added.This complaint was updated on: aug 18, 2017.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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