(b)(4).Concomitant medical product: 00625006530-bone scr 6.5x30 self-tap-64629272, 010000663- g7 pps ltd acet shell 52e-6554683, 010000857-g7 neutral e1 liner 36mm e-6623355.Two acetabular screw product identifications were reported in conjunction with this event.It is unknown after follow-up attempts which device pushed or pulled through the cup.X-ray report also confirms that only one of the screws extended through the screw hole.The information for the second screw is as follows: item name: bone scr 6.5 x 30 self-tap, catalog number: 00625006530, lot number: 64629272, expiration date: dec 31, 2029 manufacture date: jan 22, 2020.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Lot: 64629272, bone scr 6.5x30 self-tap, d4: udi: (b)(4).Reported event was confirmed via review of radiographs by a health care professional.Review of the available records identified the following: one of the two acetabular fixation screws extends through the screw hole and does not affix the acetabular implant.No other findings related to the reported event were noted.Review of the device history records identified no deviations or anomalies during manufacturing.Supplier's device history records were not reviewed as the receiving inspection report indicated that the hex dimensions, overall length, major diameter and minor diameter of the threads are measured during incoming inspection (sampling plan used).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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