Catalog Number 75002699 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Injury (2348)
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Event Date 01/01/1901 |
Event Type
Injury
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Event Description
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It was reported a stem loosening after implantation.No more information was reported.
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Manufacturer Narrative
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Results of investigation: it was reported that an unknown sl plus stem was loosening after implantation.The device in question was not sent back for investigation and no batch number was communicated.An appropriate investigation could therefore not be conducted.The stated failure mode could not be confirmed and the root cause stays undetermined.Based on available information the need for corrective action is not indicated.The complaint will be reopened should additional information be received.Smith and nephew will continue to monitor this device for similar issues.
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Event Description
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It was reported that a patient had a fall and later x-ray showed a sintering of the stem.A revision surgery of the stem was performed due to loosening.
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Manufacturer Narrative
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Roi updated: this complaint from germany reports a loose hip stem that required a revision.The reported stem is a sl-plus standard stem size 3, which was used in treatment.The primary surgery was performed in (b)(6) 2018.The complaint was re-opened due to provided clinical documentation.Product or batch number are still missing.Thorough investigations could not be performed due to insufficient information.The examination of the clinical documentation was performed.The patients fall cannot be ruled out as a contributing factor to her subsided and loosened stem prosthesis.Without the supporting lab/pathology results and/or the analysis of the explanted components, the root cause of the reported effusion cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Implant loosening is a known possible side effect and mentioned in the hip ifu 12.23.Should information become available, this complaint can be re-assessed.At that time of investigation the root cause remains undetermined.Smith + nephew will continue to monitor this device for similar issues.
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Manufacturer Narrative
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Updated results of investigation: this complaint from germany reports a loose hip stem that required a revision.The reported stem is a sl-plus standard stem size 3, which was used in treatment) and wasn't sent back for investigation.The primary surgery was performed in (b)(6) 2018.The complaint was re-opened due to provided clinical documentation.Batch number is still missing.Thorough investigations could not be performed due to insufficient information.One similar complaint have been identified for this part number in the last five years.This failure mode will continue to be monitored.No corrective action is deemed required at this moment.The examination of the clinical documentation was performed.The patients fall cannot be ruled out as a contributing factor to her subsided and loosened stem prosthesis.Without the supporting lab/pathology results and/or the analysis of the explanted components, the root cause of the reported effusion cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Implant loosening is a known possible side effect and mentioned in the hip ifu 12.23.Should information become available, this complaint can be re-assessed.At that time of investigation the root cause remains undetermined.
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Search Alerts/Recalls
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