Model Number N/A |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2: foreign ¿ australia multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 03091 the customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.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 shell would not come off the shell inserter after impaction.A new shell and handle were used to complete the surgery.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: d4; d9; g3; h2; h3; h4; h6.Visual examination of the returned product identified the devices were returned detached from each other as shown in the photograph labeled overall with scale.There is no thread damage to either device.There is some staining on both the interior and exterior of the shell.Did mate the shell and the inserter together and then disassembled them with no issues.Unable to confirm complaint as the inserter and shell can be assembled and disassembled without force.110003450 - review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.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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No further information is available at the time of this report.
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Search Alerts/Recalls
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