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Catalog Number UNK-HIP |
Device Problems
Corroded (1131); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Cardiac Arrest (1762); Foreign Body Reaction (1868); Memory Loss/Impairment (1958); Muscle Weakness (1967); Pain (1994); Tissue Damage (2104); Osteolysis (2377); No Code Available (3191)
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Event Date 12/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Event Description
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Litigation alleges patient was revised to address pain, elevated ions, and metallosis.Staining around the synovium and corrosion around the femoral head and stem and between the stem and sleeve were also noted.
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Manufacturer Narrative
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Examination of the reported devices was not possible as they were not returned.The investigation can draw no conclusion regarding the reported event with the information available.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Event Description
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Update jun 22, 2017: legal medical records received.In addition to what was previously alleged , pfs alleges reduced muscle strength, memory loss and decreased daily activities.After review of the medical records for the mdr reportability, patient was revised due to pain and osteolysis secondary to adverse tissue response.Revision notes stated that posterior capsule was intact, but distended.The joint was filled with dark brown gritty paste consistent with foreign body reaction.There was lysis into the greater trochanter around the margins of the sleeve of the hip stem, but the sleeve was well fixed to bone and not loose.There was also lysis around the margins of the acetabular component and through the open screw holes and somewhat into the ischium, but the cup appeared to be well fixed and not loose.The synovium was dark brown stained approximately a millimeter and half thick.I t was also reported that there was corrosion visible between the femoral head and the neck taper and also there was corrosion between the stem and the sleeve.It was also stated that, radiographically, there has been some migration of the femoral stem into varus.Laboratory results for metal ions were below 7ppb.No part/lot information received.This complaint was updated on jun 29, 2017.
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Manufacturer Narrative
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Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.Depuy considers the investigation closed at this time.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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Event Description
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Update ad 30 may 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf record.In addition to what were previously alleged, ppf alleges metallosis, stroke and elevated metal ions.
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Event Description
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Update ad 30 may 2018: com-(b)(4) has been re-opened under pc-(b)(4).Due to the receipt of ppf and medical record.In addition to what were previously alleged, ppf alleges metallosis and elevated metal ions.After review of medical records for the mdr reportability, there is no revision notes provided.It was stated that patient had pinnacle cup, single screw, metal liner, s-rom head, s-rom stem and s-rom sleeve implanted.Implant sticker sheets were not provided.Revision stickers sheets were provided and indicated that a new head, liner and stem were implanted on (b)(6) 2016.Doi: sep 24, 2002-dor: dec 29, 2016 (right hip).Patient is bilateral.Pc-(b)(4).For the left hip.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 code(s) was not provided.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.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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Search Alerts/Recalls
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