SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP IMPACTOR PART FOR HANDLE; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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Model Number 75023346 |
Device Problems
Break (1069); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Complaint reference number: (b)(4).
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Event Description
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It was reported that during thr surgery, a polarcup impactor part for handle was chipped.Surgery was resumed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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H3, h6: it was reported that during a total hip replacement, the polarcup impactor part for handle was chipped.No patient complications were reported.The device used 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 performed complaint history review for the complaint device revealed no previous complaints for the same batch and 7 additional similar complaints for the same product number over the past 12 months with similar failure mode.Due to insufficient information it is not possible to perform a review of past corrective actions.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.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.There is no need for further actions because of the limited information provided.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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Search Alerts/Recalls
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