SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 43/22 NON-CEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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Catalog Number 75018942 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Internal reference number: (b)(4) h10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
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Event Description
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It was reported that during thr surgery one (1) polarcup xlpe insert 43/22 non-cem was placed in the press with the 22 head.It seemed to have created a vacuum, as the head moved inside the insert and appeared to be fine.However, when placing the insert on the patient and reducing it, the insert came loose from the head.They had to remove the head from the stem.The process of inserting the head into the insert was repeated, and when reducing it again, the exact same issue occurred.The treatment was resumed after a significant delay, using a s+n back-up device, which was implanted correctly.No injuries were reported as a consequence of this issue.
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Manufacturer Narrative
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It was reported that during total hip replacement surgery one (1) polarcup xlpe insert 43/22 non-cem was placed in the press with the 22 head.It seemed to have created a vacuum, as the head moved inside the insert and appeared to be fine.However, when placing the insert on the patient and reducing it, the insert came loose from the head.They had to remove the head from the stem.The process of inserting the head into the insert was repeated, and when reducing it again, the exact same issue occurred.The treatment was resumed after a significant delay, using a s+n back-up device, which was implanted correctly.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and no additional similar complaints for the same product number over the past 12 months with similar failure mode.Review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The performed investigation does not lead to an accurately determined cause.There is no indication that the reported devices failed to meet manufacturing specifications upon release for distribution.There is no need for further actions.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.
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