The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.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.Zimmer's reference number of this file is (b)(4).
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Investigation results were made available.It was discovered that the product natural hip liner is manufactured by zimmer (b)(4), inc.Zimmer (b)(4) will invalidate this report from the system as zimmer (b)(4) is not the manufacturer of this product.This product will be further included in the existing case (b)(4) from zimmer inc., (b)(4).The case (b)(4) will further report the product metasul head only (mfr 9613350-2015-01264).Please invalidate this report mfr 9613350-2015-01265 from your system.(b)(4).
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