Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: 00625006535, item name: bone scr 6.5x35 self-tap.Lot # j7410192.G2: foreign: canada.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the cup was implanted and needed a screw for better fixation, the surgeon thinks he over tightened the screw causing it to go through the cup.Cup and screw and liner was removed after intra op x-ray was preformed and replaced with identical implants.There is no additional information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: limited evaluation of a right total hip arthroplasty with single screw which has penetrated through the implant and implanted fully into bone.It was stated the surgeon thinks he may have over tightened the screw but 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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Event Description
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There is no update to the prior event description provided.
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Search Alerts/Recalls
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