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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 Problem Insufficient Information (3190)
Patient Problems Muscular Rigidity (1968); Pain (1994); Injury (2348); Cancer (3262)
Event Date 02/26/2020
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Not returned to the manufacturer.
 
Event Description
A patient specific prescription form was provided for the patient's right proximal tibia with the following information: indication/ diagnosis: limb length discrepancy.Reason for revision: limb length discrepancy, muscle contracture.Notes: save femoral component.The overall replacement should cover the extension (~200-220 mm).Additional information provided by the rep: "the patient has a pain during the knee extension and a muscle contracture.This is the reason the implant cannot be extended.The issue cannot be solved by shortening the implant, the surgeon wishes to replace this.".
 
Manufacturer Narrative
Updated b2.: event: an event regarding leg length discrepancy and muscle contracture involving a jts proximal tibia was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as no items were returned.Clinician review: the implant in situ was for a jts proximal tibial replacement which was inserted in aug2017.The surgeon reported that the patient had muscle contracture and limb length discrepancy.The ct scan provided doesn¿t include the full leg, so the comparison of the limb length is not possible.However, the ct scan does show that the implanted knee is in flexion which might indicate the contracture of the muscle.Another observation is that the right (affected) tibial is over 20 mm longer than the left (normal) tibial which may cause the leg length discrepancy.In general, the radiographic review can confirm the clinical report.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 02aug2017 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from (b)(6) 2017 to present for similar reported events regarding limb length discrepancy involving jts proximal tibia.There has been 1 other event.Conclusions: an event regarding leg length discrepancy and muscle contracture involving a jts proximal tibia was reported.The event was confirmed by medical review.The exact cause of the event could not be determined because further information such as the primary operative report as well as patient history and follow up notes are 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.H3 other text : device not returned.
 
Event Description
A patient specific prescription form was provided for the patient's right proximal tibia with the following information: indication/ diagnosis: limb length discrepancy.Reason for revision: limb length discrepancy, muscle contracture.Notes: save femoral component.The overall replacement should cover the extension (~200-220 mm).Additional information provided by the rep: "the patient has a pain during the knee extension and a muscle contracture.This is the reason the implant cannot be extended.The issue cannot be solved by shortening the implant, the surgeon wishes to replace this.".
 
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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
GB  WD6 3SJ
MDR Report Key9859442
MDR Text Key184922350
Report Number3004105610-2020-00069
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 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 20850
Was Device Available for Evaluation? No
Date Manufacturer Received04/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age16 YR
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