ZIMMER MANUFACTURING SWITZERLAND GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14; PROSTHESIS HIP
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Model Number N/A |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign source: japan.Concomitant medical products: medical product: e1 ringloc bipolar 28x45mm, catalog no: 110010454, lot no: 395150.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 ceramic head did not articulate correctly within the e1 bipolar liner.The procedure was completed with a different head and liner.
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Manufacturer Narrative
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(b)(4).Head and liner were returned for investigation.No signs of heavy damage on any of the devices.Some slight metallic smearing on the inner surface of the head where the proximal taper is inserted.Functional test was performed, and event can be confirmed: the head does not move smoothly.The device is used for treatment.A review of the device history records identified no related deviations or anomalies during manufacturing.Review of the available information indicates the device was assembled per technique, was released in a conforming state, and is functioning as expected per the documented design requirements.No device failure was identified.Ceramtec review of the dimensional protocol states: the measurement results show that the dimensions were within the specified tolerance.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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Event Description
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No further event information available at the time of this report.
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