ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA STEMMED CEMENTED TIBIAL COMPONENT LEFT SIZE H; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant 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 implant box was received crushed.The shrink-wrap appeared intact, however, upon examination, the seal of the inner sterile container was slightly open, compromising sterility.No adverse events were reported as a result of this malfunction.
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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: b4, g3, g6, h2, h3, h6, h10.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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