Model Number N/A |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).D10: cat# unknown lot# unknown advantage 54mm acetabular cup.G2: foreign: country: canada.Customer has indicated that the product remains implanted and will not be returned to zimmer biomet for investigation.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 a cemented 54mm, competitor acetabular cup was implanted.A -6mm dm liner (48mm) was opened, only to discover it was too large.The patient had pain and suspected infection, and a stage 1 prostalac was performed.The zimmer biomet liner was placed in the cup regardless because it was a prostalac total hip arthroplasty and will need revision.The surgeon was satisfied with tighter mobility.It was reported that the liner was believed to either be mislabeled or the improper liner type was provided in the loaner kit.It might be due to it being a zimmer biomet bearing and not a competitor bearing.Regarding delay of surgery, there was some time to evaluate options, but not enough to be measured.It was reported that the patient had old worn-out implants from an old surgery.The worn-out implants were from an unspecified company but were not zimmer biomet implants.There was no reported harm or injury to the patient.No additional information is available.
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Event Description
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It was reported that the surgeon trialed first with provisional, but when the corresponding implant box was opened, the implant inside was larger than the provisional.It was deduced that the wrong sized implant was contained inside the box and the wrong label was included on the box.No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4;b5;h2;h6 the following section was corrected: g3 customer has indicated that the product remains implanted and will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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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 history records identified no related deviations or anomalies during manufacturing.Medical records were not provided.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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