Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10.Metasulâ® epsilonâ¿¢ standard insert 55/32 item# 437232155 lot# unknown the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported approximately one month ago that a patient underwent a hip arthroplasty on an unknown date.Subsequently, it was confirmed that the patient underwent a revision for loosening of the stem.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Device is used for treatment.Due to insufficient product information, the compatibility of the involved products could not be verified.A review of the complaint history could not be performed due to missing reference and lot numbers.Two radiographs were received and reviewed by a radiologist.Both images shows the left hip of the patient.In both case it is possible to see a cement fixation of the acetabular cup.As the femoral components are different, it is possible to conclude that the images are taken at a different timepoint: most likely x-ray 2 is taken before revision surgery, while x-ray 1 is taken after revision surgery.In both cases cortical thickening is present both medially and laterally within the proximal femoral diaphysis.No acute fracture.Radiolucency along the lateral aspect of the proximal femoral component on x-ray 2 is present that might indicate loosening of the femora stem.With the available information, a definitive root cause could not 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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Diligence is complete and additional information on the reported event is unavailable at this time.
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Search Alerts/Recalls
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