Catalog Number 999890139 |
Device Problems
Metal Shedding Debris (1804); Insufficient Information (3190)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Joint Swelling (2356); No Information (3190); No Code Available (3191)
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Event Date 02/19/2014 |
Event Type
Injury
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Event Description
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Asr revision; asr xl- right; reason(s) for revision: unknown.(b)(6).Lot number for femoral head does not match product code - therefore unable to attain manufacturing location.
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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 u.S.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.Ref.(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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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.Depuy still considers this case closed to capa.
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Event Description
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Asr revision, asr xl- right, reason(s) for revision: unknown.(b)(6).Lot number for femoral head does not match product code - therefore unable to attain manufacturing location.Update 29 apr 2014 - marked lot number for fem head as unknown.Taken from spreadsheet.Surgeon confirmation form received (b)(6) 2014.Revision reasons added.Surgery date amended.Stem and taper sleeve added.Additional hospital added.Reason(s) for revision: pain, serious metallosis, high metal ion level in blood co 69.0 cr 17.7.Confirmation of femoral head lot number received (b)(6) 2014.Update 13 apr 2015: rec'd legal letter from (b)(6) - marked com as legal, patient name, dob, sex, amended doi, reasons for revision: loculated effusion, all product reason for revision, brand name for stem.All mw fields.(b)(4).
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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.(b)(4).Depuy still considers this case closed to capa.
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Event Description
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Asr revision, asr xl- right, reason(s) for revision: unknown.(b)(6).Lot number for femoral head does not match product code - therefore unable to attain manufacturing location.Update (b)(6) 2014 - marked lot number for fem head as unknown.Taken from spreadsheet.Surgeon confirmation form received (b)(6) 2014.Revision reasons added.Surgery date amended.Stem and taper sleeve added.Additional hospital added.Reason(s) for revision: pain, serious metallosis, high metal ion level in blood co 69.0 cr 17.7.Confirmation of femoral head lot number received (b)(6) 2014.
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Manufacturer Narrative
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Depuy still considers this case closed to capa.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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Additional information received.
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Search Alerts/Recalls
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