Model Number PHA00264 |
Device Problems
Corroded (1131); Appropriate Term/Code Not Available (3191)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032)
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Event Type
Injury
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Manufacturer Narrative
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The alleged complaint could not be confirmed.Microport post market quality was made aware of this revision through a microport distributor.Per the provided incident report, the surgeon indicated that this patient was revised due to a "metal allergy." the length of implantation is unknown.Descriptions of the femoral components were provided, but no specific item numbers or lots are known.The revised products have not been returned to microport for investigation.No images, operative notes, or other clinically relevant documentation has been provided to confirm the complaint.The microport hip systems package insert (150803-8) lists "allergic reactions to materials; metal sensitivity; or reactions to wear debris that may lead to histological reactions, pseudotumor and aseptic lymphocytic vasculitis-associated lesions (alval)" as possible adverse effects of total hip arthroplasty.There were no trends identified per mpo trending procedures.No conclusions can be made from the available information.This issue will continue to be monitored through complaint tracking.
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Event Description
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Allegedly, femoral implants removed and acetabular liner exchanged due to complications from metal allergy (per surgeon).
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Event Description
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Allegedly, femoral implants removed and acetabular liner exchanged due to complications from metal allergy (per surgeon).Mrn: (b)(4).Additional information received on april 11,2022: allegedly, on or about (b)(6) 2021, patient reported for revision surgery of her failed left hip prosthesis.It was recommended a revision surgery after patient presented with pain and lack of mobility.Revision surgery was necessary because the device failed due to corrosion at the neck-stem junction of the device.On or about (b)(6) 2021, it was discovered that the left-sided device failed due to corrosion of the oblong taper of the profemur cocr modular neck where it seated in the pocket of the profemur titanium stem, which caused physical injury to patient.
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Search Alerts/Recalls
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