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Catalog Number 157011135 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Inflammation (1932); Pain (1994); Discomfort (2330); Joint Swelling (2356); No Code Available (3191)
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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.(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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Litigation alleges patient suffers from extreme pain, discomfort, soreness; malaise; swelling; loss of energy; immobilization and both acute localized damage to tissue and/or bone surrounding the acetabulum and elevated ions.
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Manufacturer Narrative
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Litigation alleges patient suffers from extreme pain, discomfort, soreness; malaise; swelling; loss of energy; immobilization and both acute localized damage to tissue and/or bone surrounding the acetabulum and elevated ions.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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