Lot Number 1908650 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Arthralgia (2355)
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Event Date 11/02/2023 |
Event Type
Injury
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Event Description
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Patient underwent revision surgery for painful knee.During the revision surgery the following implants were explanted: size 3, resurfacing axial pin, size 3, resurfacing femur, tibial hinge with rotational stop, and canal filling stem 12x 100mm.The date and facility of the original surgery is unknown.
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Manufacturer Narrative
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The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.The following mdrs have also been submitted for this patient: #3013450937-2023-00299; #3013450937-2023-00300; #3013450937-2023-00302.
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Manufacturer Narrative
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On (b)(6) 2023, (b)(6) reported that a 68-year-old male patient who had allegedly suffered from knee pain, underwent a revision surgery to replace the eleos distal femur replacement with larger-sized resurfacing femur, axial pin, and cemented stem extension.All inspection and manufacturing data was reviewed for revised eleos implants; the lots were found to be conforming to specifications and no manufacturing abnormalities were observed.As detailed in section 3.5 of the complaint report, the ifu and surgical technique documentation identifies elements such as patient contraindications, patient selection factors, surgical procedures/techniques and other precautions/conditions that may contribute to adverse effects.The root cause of this complaint was not determined.Based on the review of device history records, the investigation concluded that the root cause of the knee pain was not related to the design, manufacture, and/or sterilization of previously implanted eleos implants.The mdrs listed below are related to this report.3013450937-2023-00299; 3013450937-2023-00300; 3013450937-2023-00301; 3013450937-2023-00302.
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Event Description
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On (b)(6) 2023, (b)(6) reported that a 68-year-old male patient who had allegedly suffered from knee pain, underwent a revision surgery to replace the eleos distal femur replacement with larger-sized resurfacing femur, axial pin, and cemented stem extension.
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Search Alerts/Recalls
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