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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problems Insufficient Information (3190); Unclear Information (4052)
Patient Problems Injury (2348); Cancer (3262); Unequal Limb Length (4534)
Event Date 05/30/2019
Event Type  Injury  
Manufacturer Narrative
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.Device evaluated by mfr: remains implanted.
 
Event Description
A patient specific prescription form was submitted for patient's right proximal tibia.Diagnosis is "jts tibia component revision".Note indicates a leg length discrepancy, the overall replacement should cover the discrepancy, and save the tibial stem".
 
Event Description
A patient specific prescription form was submitted for patient's right proximal tibia.Diagnosis is "jts tibia component revision".Note indicates a leg length discrepancy, the overall replacement should cover the discrepancy, and save the tibial stem".Update (b)(6) 2020 wg: the proposed surgery on (b)(6), 2019 was cancelled.A new patient specific prescription form has been received.Noted: "max extension.Save femoral component.Overall replacement is about 190mm.Surgeries in (b)(6) 2014".
 
Manufacturer Narrative
Corrected data: d2a.Additional manufacturer narrative: reported event: an event regarding a leg length discrepancy of 20 mm involving a jts proximal tibia device was reported.The event was confirmed through x-ray review.Method & results: device evaluation and results: not performed as product was not returned- it has not been reported if revision surgery has taken place or not.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for jts proximal tibial replacement, which was inserted on (b)(6) 2014.The surgeon reported a leg length discrepancy of 20mm.The ct scans provided showed that the implant has been extended by 41mm which has nearly reached to its maximum capacity of 50mm.Therefore, the reason for revision has been confirmed.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported device.Conclusions: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for jts proximal tibial replacement, which was inserted on (b)(6) 2014.The surgeon reported a leg length discrepancy of 20mm.The ct scans provided showed that the implant has been extended by 41mm which has nearly reached to its maximum capacity of 50mm.Therefore, the reason for revision has been confirmed.On the 25aug2020 it was reported that the device has reached max extension and, therefore, it needs to be revised.There is no device failure; the device functioned as intended and is being replaced, as anticipated, to allow for the patient¿s continued growth.The jts device successfully fulfilled its function and therefore no further investigation is required.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.H3 other text : device not returned.
 
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Brand Name
PROXIMAL TIBIA JTS
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK  WD6 3SJ
MDR Report Key8735121
MDR Text Key149211060
Report Number3004105610-2019-00078
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K092138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 18336
Was Device Available for Evaluation? No
Date Manufacturer Received09/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age11 YR
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