DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX50OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
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Catalog Number 121887350 |
Device Problems
Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Host-Tissue Reaction (1297); Itching Sensation (1943); Pain (1994); Tinnitus (2103); Vertigo (2134); Dizziness (2194); No Code Available (3191)
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Event Date 05/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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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It was reported that the patient was revised to address pain.The 36+5 metal head was removed and the 36x50 metal on metal liner was removed without incident.The cup and stem where well fixed and the wound was washed out.A 32x50 neutral altrx poly liner was inserted and 32+9 delta ts ceramic head was implanted.Doi: unk, dor: (b)(6) 2019, left hip.
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Manufacturer Narrative
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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.Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot =null.Device history batch = null.Device history review = null.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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Manufacturer Narrative
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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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : null.Device history batch : null.Device history review : null.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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Manufacturer Narrative
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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.Product complaint # (b)(4).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.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).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.No code available (3191) used to capture blood heavy metal increased and device revision or replacement.
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Event Description
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Update ad (b)(6) 2019: (b)(4) has been re-opened due to the receipt of unf and medical records.After a review of the medical records, the patient was revised to address left hip metal on metal corrosion.Operative notes reported a small gush of dark fluid from the hip joint and metal-on-metal corrosion of the trunnion as well as behind the line.Patient visit note reported of tinnitus, vertigo, dizziness, itchiness, and elevated cobalt and chromium levels.Stem was added to the ips due to the reported elevated cobalt and chromium levels doi: (b)(6) 2009.Dor: (b)(6) 2019.Left hip.
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Search Alerts/Recalls
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