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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE SMILES KNEE CIRCLIP MK2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STANMORE IMPLANTS WORLDWIDE SMILES KNEE CIRCLIP MK2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number SMCIC01
Device Problems Unstable (1667); Loss of Osseointegration (2408); Naturally Worn (2988)
Patient Problems Injury (2348); Cancer (3262)
Event Date 01/24/2020
Event Type  Injury  
Manufacturer Narrative
The reported device is similar to a device approved for compassionate use in the united states.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.There have been no other similar events for the lot referenced.Device not returned.
 
Event Description
A patient specific prescription form was received with note "revision of femoral component." in a clinician letter, the following is reported: "clinically, his leg is about 3 cm short on the right (where existing implants are) than his left.His wound remains well healed with no evidence of infection.His gastric flap appears to be in good condition.He has a very good straight leg raise with no lag at all and he flexes to about 90°.There is a lot of instability in the medial lateral plane.In terms of treatment, i think he would benefit from re bushing but also exchange of the smiles femoral component to a new one due to the fact it is loose.At the same time he will need a radical debridement and excision of what likely is to be wear debris.".
 
Event Description
A patient specific prescription form was received with note "revision of femoral component." in a clinician letter, the following is reported: "clinically, his leg is about 3 cm short on the right (where existing implants are) than his left.His wound remains well healed with no evidence of infection.His gastric flap appears to be in good condition.He has a very good straight leg raise with no lag at all and he flexes to about 90°.There is a lot of instability in the medial lateral plane.In terms of treatment, i think he would benefit from re bushing but also exchange of the smiles femoral component to a new one due to the fact it is loose.At the same time he will need a radical debridement and excision of what likely is to be wear debris.".
 
Manufacturer Narrative
An event regarding rebushing involving a patient specific proximal tibia was reported.The event was not confirmed.Method and results: product evaluation and results: not performed as no items were returned.Clinician review: the implant in situ was for a proximal tibial replacement which was inserted on 4th dec 2014.The surgeon reported that the operated leg is shorter than the opposite leg, the femoral stem is loosed and instability of the knee.The ct scan provided showed that the operated femur is 45 mm shorter than the opposite femur and there are massive radiolucent lines along the femoral stem between the stem and cement, and between the cement and bone.The cortical bone of the femur has undergone significant bone resorption and osteolytic lesions.The above observation can confirm the reason for revision.However, the instability of the knee can not be assessed by the image.Product history review: review of the product history records indicate 96 devices were manufactured and accepted into final stock on 19aug2010 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed for similar events regarding rebushing lot b7864 there has been 1 other events for the lot referenced.Conclusions: an event regarding rebushing involving a patient specific proximal tibia was reported.The exact cause of the event could not be determined because further information such as retrieval analysis and 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.
 
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Brand Name
SMILES KNEE CIRCLIP MK2
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 Key9726275
MDR Text Key183737739
Report Number3004105610-2020-00036
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2015
Device Catalogue NumberSMCIC01
Device Lot NumberB7864
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age39 YR
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