Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Material Disintegration (1177); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Depression (2361); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
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Event Date 03/21/2017 |
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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Litigation records of pinnacle received.Litigation alleges pain, suffering, disability, irritation and discomfort.Doi: (b)(6) dor: (b)(6) 2017 (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.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.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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Pfs and medical records received.In addition to what were previously alleged, pfs alleges limited mobility, walking difficulty, loss of sexual activity and depression.After the review of medical records, it was reported that the patient was revised to address metallosis as indicated by the aspirated serous brown fluid, elevated metal ions and tissue necrosis due to metal debris.Revision notes reported metallosis along the stems¿s trunnion.Clinical notes also reported soreness.There are no lab results provided.Added stem due to reported elevated metal ions.
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Manufacturer Narrative
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Product complaint # :(b)(4).
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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.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.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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Search Alerts/Recalls
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