Model Number 2500L004E |
Device Problems
Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Insufficient Information (4580)
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Event Date 01/05/2022 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this adverse event: 3013450937-2022-00046, 3013450937-2022-00048, 3013450937-2022-00049, 3013450937-2022-00050, 3013450937-2022-00051, 3013450937-2022-00052 and 3013450937-2022-00053.
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Event Description
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It was reported that the patient presented with an alleged disassociated stem on the resurfacing femur and an alleged infection on (b)(6) 2022, after receiving a proximal tibia replacement surgery on (b)(6) 2020.The implanting surgeon performed revision surgeries on the patient to wash the patient out on (b)(6) 2022 and (b)(6) 2022.The surgeon also performed a revision surgery on (b)(6) 2022 to remove all the implants that were implanted on (b)(6) 2020 during the original the proximal tibia replacement surgery.It was also reported that the surgeon plans to put in replacement implants when the infection clears up.No revision surgery to do this has been scheduled yet.No additional information regarding this adverse event has been provided.
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Manufacturer Narrative
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This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the alleged implant loosening could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added.G3: date received by manufacturer added.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4117: device not accessible for testing.H6: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.
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Event Description
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It was reported that the patient presented with an alleged disassociated stem on the resurfacing femur and an alleged infection on (b)(6) 2022, after receiving a proximal tibia replacement surgery on (b)(6) 2020.The implanting surgeon performed revision surgeries on the patient to wash the patient out on (b)(6) 2022 and (b)(6) 2022.The surgeon also performed a revision surgery on (b)(6) 2022 to remove all the implants that were implanted on (b)(6) 2020 during the original the proximal tibia replacement surgery.It was also reported that the surgeon plans to put in replacement implants when the infection clears up.No revision surgery to do this has been scheduled yet.No additional information regarding this adverse event has been provided.
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Search Alerts/Recalls
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