Catalog Number MMH99880046 |
Device Problems
Degraded (1153); Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
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Patient Problems
Anemia (1706); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Discomfort (2330); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)
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Event Date 09/22/2020 |
Event Type
Injury
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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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Event Description
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Surgeon confirmation form received.It was stated that a mitch product was implanted.Patient experienced metal debris (armd), metallosis, aseptic lymphocytic vasculitis associated lesions (alval), and trauma.Patient alleges that hip had shattered inside and that x-ray revealed that prosthesis had snapped.Doi: (b)(6) 2008 - dor: (b)(6) 2020 (left hip).
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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 manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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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 manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot =a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H6 (medical device problem code) device dislodged or dislocated (a051201) is used to capture implant disassociation and implant dislocation.
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Event Description
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Claim alleges pain, limited range of motion, walking difficulty, sleeping bending, shortening of the femur and subluxation.Claimant is seeking compensation for all the damages.After review of the medical records the patient was revised to address elevated metal ion, dislocation, shattered hip device and leg disengagement dissociation of the femoral neck trunnion from the femoral stem and metallosis resulting to hip pain, discomfort, limited adl, walking difficulty, limited range of motion.Operative finding reported extensive titanium staining corroded, trunnionosis and fractured trunnion, segmental bone loss above the acetabular cup.Tissue histology reported synovitis secondary to metal body debris.Lab result shows above 7ppb.Post op complication is anemia due to excessive blood lost patient required to had 1 u prbc and was admitted in the icu.Doi: (b)(6) 2008 dor: sept 22, 2020.Affected side: left hip.
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Search Alerts/Recalls
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