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Model Number N/A |
Device Problems
Material Erosion (1214); Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)
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Patient Problems
Abscess (1690); Congenital Defect/Deformity (1782); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
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Event Date 07/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00428, 0001825034 - 2023 - 00429, 0001825034 - 2023 - 00431.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Event Description
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According to legal allegations, an initial left total hip was performed due to congenital hip dysplasia.Subsequently the patient felt a bump which progressed to increased pain and difficulty walking.The patient underwent a debridement with irrigation and pathology confirmed a neutrophilic abscess with metallosis.Later, the patient underwent the first part of a two-stage revision due to an unknown infection, metallosis, elevated metal ions, and a pseudotumor.During the stage i revision, the head was unable to be removed from the taper, extensive debridement of friable soft tissue and surrounding metallosis was performed, loss of bone around calcar and greater trochanter region, and the acetabulum was found deficient secondary to the patient¿s congenital hip dysplasia.All components, except the stem were removed and an antibiotic spacer was placed.The patient underwent stage ii of the revision.During the surgery the abductor muscles were found to be destroyed, significant scar tissue was found throughout, the acetabulum had to be recreated, and significant bone loss was found.The loose femoral stem was removed and noted to have complete destruction of the proximal femur and proximal trochanter.The surgery was completed without further complications and competitor product was implanted.Attempts have been made and no further information has been provided at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}: mechanical (g04) - head.One unknown head were returned.Upon visual inspection the head has scuffing on the outside diameter.The stem and the head were unable to be separated.Part and lot identification are necessary for review of device history records.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues bump noticed, unable to bear weight, increase in pain, definite infection.Cobalt and chromium levels noted.Loss of soft tissue.Infected left hip with pseudotumor.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further information at the time of this report.
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Search Alerts/Recalls
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