Catalog Number UNK HIP BONE SCREW |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Unspecified Infection (1930); Pain (1994); Chills (2191)
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Event Date 08/08/2006 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 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.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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On (b)(6) 2006, patient was implanted with a pinnacle total hip arthroplasty.Approximately after one month after surgery began developing fevers, chills and excessive pain in right hip.Blood cultures were positive for staph aureus.On (b)(6), 2006, patient was revised due to infected right total hip arthroplasty and had an resection arthroplasty, right total hip with placement of a high-dose antibiotic loaded cement spacer.On (b)(6) 2006, patient had a reimplantation of total hip arthroplasty (pinnacle acetabular cup, metal liner with two screws s-rom stem).Doi: (b)(6) 2006 ; dor: (b)(6) 2006; right hip.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary; the device associated with this report was not returned to depuy synthes for evaluation.The photographs attached were reviewed, however they do not represent the current complaint condition.Therefore the investigation could not draw any conclusions about the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot; a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the investigation was not able to retrieve the required lot code.
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Search Alerts/Recalls
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