Model Number N/A |
Device Problem
Difficult to Remove (1528)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Source: (b)(6).Concomitant medical products: catalog number: 110010245 lot number: 6815878 brand name: g7 shell.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00090.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 that during an initial hip arthroplasty, the inserter would not disengage from the shell after impaction.No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A g7 shell and an inserter were returned and evaluated against the complaint.The inserter and shell remain seized together upon receipt.The devices could not be disassembled by hand and the threads could not be observed.No signs of debris or cross-threading were seen.The inserter handle is discolored.Scratches are present on the inner radius of the shell.Foreign debris is stuck within the porous coating of the shell.Complaint sample was evaluated and the reported event was confirmed.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.Root cause could not 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 event information available at the time of this report.
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Search Alerts/Recalls
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