Catalog Number 999890143 |
Device Problems
Loss of or Failure to Bond (1068); Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 02/06/2014 |
Event Type
Injury
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Manufacturer Narrative
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Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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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New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint - (b)(4).Asr - revision due to cup loosening.Implant date: (b)(6) 2006.Revision date (b)(6) 2011.Update received 6th febuary, 2014.Hip side and surgeon added.Implant date and surgery date amended.(b)(4) number added.Country amended to (b)(6) in line with claimsuite.Lot number amended for femoral head.Hip(s) to be revised: left dint 17890 has been found to be a duplicate of dint 19632.Documents transferred to this com and additional reference number and surgeon added.Update 28 oct 2015: added pain from claimsuite, any missing mw fields, man/exp dates for all products.Sm 3 nov 2015.
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Manufacturer Narrative
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New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ clinical study (b)(4); patient ref (b)(6).Asr - revision due to cup loosening.Implant date (b)(6) 2006; incorrect see below.Revision date (b)(6) 2011; incorrect see below.Update received 6th febuary, 2014.Hip side and surgeon added.Implant date and surgery date amended.Dp47 number added.Country amended to germany in line with claimsuite.Lot number amended for femoral head.Hip(s) to be revised: left (b)(4) has been found to be a duplicate of (b)(4).Documents transferred to this com and additional reference number and surgeon added.Update 28 oct 2015: added pain from claimsuite, any missing mw fields, man/exp dates for all products.Sm 3 nov 2015 update august 17, 2017 additional information received from crawford, as per review of the new information there is no update to the com.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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Manufacturer Narrative
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Depuy considers the investigation closed at this time.Should the 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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