ZIMMER BIOMET, INC. COMPREHENSIVE INSTRUMENTATION METAL IMPACTOR; INSTRUMENT - SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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Catalog Number 110029132 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The customer has not indicated whether the product will be zimmer biomet for investigation, and the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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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It was reported that during an initial procedure, the impactor tip fractured.The correct surgical technique was used.No complications, injuries, or surgical interventions were required, and no foreign bodies were retained due to this malfunction.The case was completed with a backup device without any adverse outcomes to the patient.It was reported that no further information is available.
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Search Alerts/Recalls
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