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STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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| Catalog Number UNK_STM |
| Device Problem
Failure to Advance (2524)
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| Patient Problems
No Known Impact Or Consequence To Patient (2692); Cancer (3262); Unequal Limb Length (4534)
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| Event Date 06/03/2020 |
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Event Type
Injury
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Manufacturer Narrative
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An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Device not returned.
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Event Description
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As reported by a marketing associate: "we have been informed that in a new elongation procedure, again we have not had any extension.A clinician assessment was provided which outlines the following: implant date (b)(6) 2018, left femur.In (b)(6) 2019, 7-8mm extension was achieved in two sessions, 16 minutes each.In (b)(6) 2019, patient had a metastatic recurrence of cancer and underwent chemotherapy.Treatment completed in (b)(6) 2020.In (b)(6) 2020, on three different days, attempts were made to lengthen the implant unsuccessfully ("to an average of 16 minutes (4mm) without getting the prosthesis to lengthen").The drive unit had last been serviced in march of 2020.
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Manufacturer Narrative
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Reported event.An event regarding seizing involving a jts distal femur was reported.The event was confirmed by medical review.Method and results product evaluation and results: not performed as no items were received.Clinician review: the x-ray review concluded that the the implant has not been extended since (b)(6) 2019.Product history review: review of the product history records indicate (b)(4) was manufactured and accepted into final stock on 16apr2018 with no reported discrepancies.Complaint history review: there have been 12 other events.Conclusions: an event regarding seizing involving a jts distal femur was reported.The event was confirmed by medical review.It was reported that the patient had two successful lengthening procedures in (b)(6) 2019.Subsequently the patient had a metastatic relapse with surgery and cycles of chemotherapy.After the cycles, in (b)(6) 2020, another attempt was made to perform the lengthening without success and the event was reported to complaints team.In total 5 unsuccessful attempts were made with 2 different jts drive units.The sales rep reported that the jts drive units were also boosted.If there are no regular lengthening intervals, there is a creation of fibrous tissue around the device that can prevent the device from extending.The sales rep discussed with the senior manager in design (who reviewed the case) about the possibility of operating the patient to remove the fibrous tissue and check that the piston is not mechanically obstructed.The exact cause of the event could not be determined because further information such as operative report is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.
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Event Description
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As reported by a marketing associate: "we have been informed that in a new elongation procedure, again we have not had any extension.A clinician assessment was provided which outlines the following: implant date (b)(6) 2018, left femur.In (b)(6) 2019, 7-8mm extension was achieved in two sessions, 16 minutes each.In (b)(6) 2019, patient had a metastatic recurrence of cancer and underwent chemotherapy.Treatment completed in (b)(6) 2020.In (b)(6) 2020, on three different days, attempts were made to lengthen the implant unsuccessfully ("to an average of 16 minutes (4mm) without getting the prosthesis to lengthen").The drive unit had last been serviced in march of 2020.Update as reported: "unfortunately, today the second lengthening procedure and it¿s x-ray verification was done with no success.They tried to lengthen with 2 different jts units with no lengthening at all.The problem must be in the implant." an x-ray was provided.
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Event Description
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As reported by a marketing associate: "we have been informed that in a new elongation procedure, again we have not had any extension.A clinician assessment was provided which outlines the following: implant date (b)(6) 2018, left femur.In march 2019, 7-8mm extension was achieved in two sessions, 16 minutes each.In (b)(6) 2019, patient had a metastatic recurrence of cancer and underwent chemotherapy.Treatment completed in (b)(6) 2020.In (b)(6) of 2020, on three different days, attempts were made to lengthen the implant unsuccessfully ("to an average of 16 minutes (4mm) without getting the prosthesis to lengthen").The drive unit had last been serviced in (b)(6) of 2020.Update as reported: "unfortunately, today the second lengthening procedure and it¿s x-ray verification was done with no success.They tried to lengthen with 2 different jts units with no lengthening at all.The problem must be in the implant." an x-ray was provided.Update (b)(6) 2020 - the sales rep reported that a procedure was performed to remove the fibrous tissue to leave the implant clean without any fibrous tissue around it.A lengthening attempt was performed on (b)(6) 2020 with no success.
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Manufacturer Narrative
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Corrected data: b1, h1.Additional information received on (b)(6) 2020 alleges that the reported event involved a procedure to remove fibrous tissue.This supplemental report (#2) is being filed to update the type of reportable event to serious injury.Additional manufacturer narrative: an event regarding seizing involving a jts distal femur was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as no items were received.Clinician review: the x-ray review concluded that the implant has not been extended since (b)(6) 2019.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on (b)(6) 2018 with no reported discrepancies.Complaint history review: there have been 12 other events.It was reported that the patient had two successful lengthening procedures in march 2019.Subsequently the patient had a metastatic relapse with surgery and cycles of chemotherapy.After the cycles, in (b)(6) 2020, another attempt was made to perform the lengthening without success and the event was reported to complaints team.In total 5 unsuccessful attempts were made with 2 different jts drive units.The sales rep reported that the jts drive units were also boosted.If there are no regular lengthening intervals, there is a creation of fibrous tissue around the device that can prevent the device from extending.The sales rep discussed with the senior manager in design (who reviewed the case) about the possibility of operating the patient to remove the fibrous tissue and check that the piston is not mechanically obstructed.On (b)(6) 2020 the sales rep reported that a procedure was performed to remove the fibrous tissue to leave the implant clean without any fibrous tissue around it.A lengthening attempt was performed on (b)(6) 2020 with no success.After reviewing this update, the senior manager in design reported that a full or partial revision may be the solution.The exact cause of the event could not be determined because further information such as operative report is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.
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