Model Number 1217-32-056 |
Device Problems
Disassembly (1168); Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); No Known Impact Or Consequence To Patient (2692); Not Applicable (3189); No Code Available (3191); Swelling/ Edema (4577)
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Event Date 04/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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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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Der states that the poly disassociated from cup. doi: (b)(6) 2016; dor: (b)(6) 2018; right hip.
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Manufacturer Narrative
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(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, a follow-up medwatch will be filed as appropriate.
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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.(b)(4) used to capture the patient code medical device removal.
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Event Description
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Litigation records received alleging that one year and four months after the primary surgery, the patient's right hip popped after bending.Diagnostic testing (according to the litigation record) has indicated that the humeral head was riding high in the acetabular compartment and that there was a dislocation.The patient was forced to undergo a head and liner exchange.The records further allege severe and permanent injury, pain, suffering, disability and the need for a revision surgery.Doi: (b)(6) 2016 - dor: (b)(6) 2018 (right 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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not bsynthes 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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: e3 initial reporter occupation: lawyer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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After review of the medical records the patient was revised to address failed right tha with liner dissociation.Pop sensation of the hip, grinding and squeaking-type sensation and pain after bending over.However, xray reported no evidence of hip dislocation.Ct scan confirmed evidence of liner dissociation.Operative note reported capsule under tension with fluid, this was black tarnished from the ceramic on metal contact.There was thick blackened synovium in the joint that were debrided.There was difficulty implanted the head due to native retroversion.
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Manufacturer Narrative
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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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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