Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Hematoma (1884); Failure of Implant (1924); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
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Event Date 03/14/2024 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).G2: report source germany.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 patient underwent right hip revision approximately 1 month post implantation due to the inlay and shell were dislocated.
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Event Description
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It was reported patient underwent right hip revision approximately 1 month post implantation due to dislocation.During the revision, the head was found firmly attached to the stem while the bipolar components were found free in the joint.The initial stem was left intact, and all other components were revised.The trochanteric muscles were re-anchored from dislocation damage.The procedure was completed without complications.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.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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Search Alerts/Recalls
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