ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M¸ 36/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD
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Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/29/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer did not receive the devices, x-rays or other source documents for review.The device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).
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Event Description
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It was reported that when opening the sterile packaged biolox delta head it was discovered a piece of lint in the packaging.Implant was not with the patient in contact.
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Manufacturer Narrative
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No trend identified.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it is reported that in the packaging of the biolox delta head there was a piece of lint detected.Packaging was opened during surgery, but the device was not used.No medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: visual examination: the returned biolox delta head shows some blood spots.The customer made an adhesive tape over the cone.A residue stuck on the tape.It looks like a dust or small hairs.Conclusion summary: the visual examination of the returned biolox head and packaging was performed in the lab because there were blood-like traces on the packaging.The visual examination of the product revealed a residue, which seems to be dust or hairs.With the given information it cannot be determined where exactly the residue was found (inner, outer blister?).Furthermore there is the possibility that the residue came on the implant in the hospital while opening the package.The review of the dhr including the packaging steps indicates that the head met all requirements to perform as intended.As a standardized process, the inner blisters are always packed in the clean room.The employees wear appropriate workwear and headgear.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).
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