STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5517-F-402 |
Device Problems
Off-Label Use (1494); Misassembly by Users (3133)
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Patient Problem
Injury (2348)
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Event Date 02/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported that the patient's right mako tka was revised due to implantation of a cr femur in a knee prepped for ps.Rep was not present for the procedure.Intra-operatively, the femur was prepped and trialed for a ps implant.After the mps would have brought the implant to the or prior to the procedure, the device would have been shown to the circulating nurse, then to the surgical tech, and shown and handed to the surgeon or surgeon's pa.Upon billing of the case, the fact that the cr femur was implanted was brought to the surgeon's attention.The surgeon took x-rays on (b)(6) 2020 and confirmed a cr femur was in the patient.The patient was then revised.Rep provided the primary usage sheet and confirmed that no further information will be available.
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Event Description
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It was reported that the patient's right mako tka was revised due to implantation of a cr femur in a knee prepped for ps.Rep was not present for the procedure.Intra-operatively, the femur was prepped and trailed for a ps implant.After the mps would have brought the implant to the or prior to the procedure, the device would have been shown to the circulating nurse, then to the surgical tech, and shown and handed to the surgeon or surgeon's pa.Upon billing of the case, the fact that the cr femur was implanted was brought to the surgeon's attention.The surgeon took x-rays on (b)(6) 2020 and confirmed a cr femur was in the patient.The patient was then revised.Rep provided the primary usage sheet and confirmed that no further information will be available.
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Manufacturer Narrative
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An event regarding incorrect selection ( knee prepped for ps femoral but implanted a cr femoral by mistake) was reported.Conclusion: the event indicates that right mako tka was revised due to implantation of a cr femur in a knee prepped for ps.Intra-operatively, the femur was prepped and trailed for a ps implant.After the mps would have brought the implant to the or prior to the procedure, the device would have been shown to the circulating nurse, then to the surgical tech, and shown and handed to the surgeon or surgeon's pa.Upon billing of the case, the fact that the cr femur was implanted was brought to the surgeon's attention.The surgeon took x-rays on (b)(6) 2020 and confirmed a cr femur was in the patient.The patient was revised on (b)(6) 2020.Based on the provided information it has been determined that this event is associated with an off-label application.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Search Alerts/Recalls
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