Catalog Number 32810505302 |
Device Problems
Loss of or Failure to Bond (1068); Fracture (1260); Malposition of Device (2616); Insufficient Information (3190)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Udi# (b)(4).Concomitant medical products: 32810502504 interchangeable humeral assembly 61405602, cement, bone surgial simplex p mlro76, restrictor, cement reality 10mm k12315.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04480.
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Event Description
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It was reported that the patient underwent an initial right elbow arthroplasty.Subsequently, the patient is planned to be revised due to unknown reason.No revision has been reported to date.No additional patient consequences were reported.
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Event Description
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Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
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Event Description
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The patient is being planned to revise due to humeral component loosening and fracture.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Search Alerts/Recalls
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