Catalog Number UNK HIP ACETABULAR LINER BI-ME |
Device Problems
Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
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Patient Problem
Joint Dislocation (2374)
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Event Type
Injury
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Event Description
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It was reported that the primary total hip replacement dislocated.
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Manufacturer Narrative
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Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : although distributed by depuy synthes joint reconstruction, the product is designed, manufactured, and labeled by the manufacturing supplier.The requirement of fda reporting, complaint investigation, root cause, and corrective action is the responsibility of the designing supplier of this item, per the supplier agreement.The product/information will be transferred to the supplier with the complaint problem statement for investigation.The results of the supplier investigation are to be populated into the depuy synthes customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process.The products were not returned, no product for investigation can be performed.No x ray has been provided, no information.All batches are released in compliance with supplier specifications.Supplier has no evidence to determine the cause of the complaint.Revision leading to implant replacement can be caused by several factors that cannot be demonstrated due to lack of information.Supplier devices involvement is unlikely in these cases.The cause of the problem cannot be confirmed.Device history lot : a review of the device history records could not be conducted due to missing identification information within the complaint detail report supplied by depuy synthes.
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Search Alerts/Recalls
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