Catalog Number 999800102 |
Device Problems
Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 09/04/2018 |
Event Type
Injury
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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.No pma/510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.Concomitant medical products: depuy asr xl fem imp size 45 hip asr femoral head; asr acetabular implant 50 acetabular cup; taper sleeve adapter 12/14 +2 hip asr femoral sleeve/augment; unknown hip femoral stem.
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Event Description
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Male.The both hips of patient received thr in (b)(6) hospital on (b)(6) 2009.Depuy asr¿ xl acetabular systems were implanted.Reportedly patient had been suffering aggressive painful.According to the recommendation of doctor the revision surgery was conducted on (b)(6) 2018 in (b)(6) hospital.The brand of products used in the revision surgery was to be advised.
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Manufacturer Narrative
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(b)(4).Investigation summary 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.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .
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Search Alerts/Recalls
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