Model Number N/A |
Device Problems
Biocompatibility (2886); Patient Device Interaction Problem (4001)
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Patient Problems
Fistula (1862); Post Operative Wound Infection (2446); Metal Related Pathology (4530)
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Event Date 05/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).G2: foreign: italy.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.H3 other text : product is unknown.
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Event Description
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It was reported that patient underwent a total hip arthroplasty and subsequently developed metallosis, pseudo-tumor and periprosthetic infection with wound fistulation.Attempts have been made and no further information has been provided.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.No further investigation is required as this issue is known and addressed in previous corrective action (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release).If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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