ZIMMER SWITZERLAND MANUFACTURING GMBH TRIAL HEAD, L, 32, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
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Model Number N/A |
Device Problems
Crack (1135); Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2- canada.Investigation of this incident is currently ongoing.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 that the trial head did not hold on to the femoral neck well.A small crack has formed but no parts fell into the patient.It was discovered during surgery but do not know when it broke.No delays.No consequences or impact on the patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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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).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records cannot be performed without having the lot number.A device used for treatment.Medical records were not provided.However, with the available information, a definitive root cause cannot be determined.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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