Catalog Number 963203000 |
Device Problems
Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 10/14/2018 |
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.
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Manufacturer Narrative
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Product complaint # (b)(4).Occupation: lawyer.(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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Claim letter received alleging pain, inability to walk without crutches, inability to move, trouble sleeping, spasms, discomfort, suffering, significant loss of amenity.Doi: (b)(6) 2017 - dor: (b)(6) 2018 (right hip).Email notification from (b)(6) received alleging infection.Primary surgery date has been updated to (b)(6) 2015 and revision date (b)(6) 2016.The revision on (b)(6) 2017 noted on the (b)(6) appendix b matches with the second stage revision mentioned on the original claim letter.It was indicated that during this date, the infection had settled and the client's hip was now put back in place.It is unknown if the definitive implants are from depuy.It should be noted that around ten days after the definitives were implanted, the patient had experienced pain again.It was also indicated that this claim is not actively litigated.Doi: (b)(6) 2015 - dor: (b)(6) 2016 (right hip).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision depuy synthesof 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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