Model Number 1217-01-052 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Pulmonary Embolism (1498); Fall (1848); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Depression (2361); Numbness (2415); Ambulation Difficulties (2544); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)
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Event Date 02/18/2019 |
Event Type
Injury
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Event Description
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Pinnacle litigation record received.Litigation alleges friction and wear between cobalt-chromium head and liner causing elevated metal ions and particles in plaintiff blood, tissue and bone resulting to inflammation, mental and emotional injuries, pain and discomfort when ambulating.Doi: (b)(6) 2010, dor: (b)(6) 2019, right hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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 device associated with this report was not received for examination.All available x-rays were reviewed.The acetabular cup was noted to have direct contact with the femoral head.Based on the x-ray evidence, it is not unreasonable to conclude that the liner and the cup got disassociated due to a liner fracture.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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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Event Description
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Medical records were received: on (b)(6) 2020 medical records note the patient is experiencing some numbness and tingling down the right leg, along with right groin pain and weakness.On (b)(6) 2021 medical records note patient has been having increased weakness of the iliopsoas muscle right hip, the patient is scheduled for an injection in the iliopsoasa muscle.On (b)(6) 2021 the patient had iliopsoas tendon injection under fluoroscopic guidance to address right hip pain, iliopsoas bursitis, tendonitis.It should be noted that these events happened after the (b)(6) 2019 right hip revision captured on (b)(4).
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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: 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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Search Alerts/Recalls
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