Catalog Number 999890143 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Disability (2371)
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Event Date 02/18/2016 |
Event Type
Injury
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Manufacturer Narrative
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No 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.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.
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Event Description
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Litigation documents received.Patient underwent a revision to address pain, disability and elevated metal ions.
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Event Description
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Update jun 09, 2017: litigation and legal claim received.In addition to what was previously alleged, it was reported that the patient had her implant on (b)(6) 2009.There is no new information added that changes the mdr decision.There are no medical records and laboratory values provided.Added the pma/510k number of the sleeve.Added the complainant information.This complaint was updated on: jun 21, 2017.
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Event Description
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Update sep 29, 2017: litigation record received.There is no new allegation.Litigation stated that patient suffered post operative complication, acute kidney injury and elevated troponin levels.This complaint was updated on oct 18, 2017.
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Manufacturer Narrative
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Additional narrative: litigation documents received.Patient underwent a revision to address pain, disability and elevated metal 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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