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Model Number N/A |
Device Problems
Material Erosion (1214); Noise, Audible (3273)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 03/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).A2: date of birth - 1945 d6a: implanted - 2009 g2: foreign ¿ denmark multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02481 the customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that approximately eleven years following a hip surgery, a revision surgery took place due to pain, increased metal ions, and a pseudotumor.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records/radiographs were provided and review of the identified findings of the reported issues.(b)(6) 2018): cobalt 9.5, chromium 14.5.(b)(6) 2019): cobalt 30.5, chromium 29.0.(b)(6) 2019): ct scan: pseudotumor formation to bilateral hips; pain and audible clunk sounds to left hip; infection rates normal; x-ray: resurfacing on the high side without suspicion of looseness or osteolysis.Nice prosthetic position.On the left side, the bimetric m2a magnum is seen without looseness or osteolysis; exam: tenderness and clear sounds from joint with movement, +1cm leg length; plan: mom left hip with symptoms, elevated metal ions, pseudotumor.Suggestion of revision asap, pt will think about it.A definitive root cause cannot be determined.Complaint is confirmed via medical records.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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It was reported that the patient underwent a revision procedure due to pain, increased metal ions, and a pseudotumor; the head, taper, and cup were revised.The head and taper were revised approximately nine years post-implantation and the cup was revised approximately thirteen years post implantation.During surgery, it was noticed that the taper was cold welded to the head.Attempts have been made and no further information has been provided.
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Search Alerts/Recalls
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