MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE FEMORAL PLATEAU PLATE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Unstable (1667); Loss of Osseointegration (2408); Insufficient Information (3190)

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.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.".

Manufacturer Narrative

An event regarding limb length discrepancy involving a patient specific proximal tibia was reported.The event was confirmed by xray review.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 (b)(6) 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: a review was not performed because no batch or catalogue numbers were provided complaint history review: a review was not performed because no batch or catalogue numbers were provided conclusions: an event regarding limb length discrepancy 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.

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

Update (b)(6) 2020 - the femoral plateau plate was never implanted.Therefore this mdr is being cancelled.

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.".

• Brand Name: FEMORAL PLATEAU PLATE
• 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 Key: 9726252
• MDR Text Key: 183566935
• Report Number: 3004105610-2020-00034
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 04/20/2020; 08/07/2020
• Supplement Dates FDA Received: 04/27/2020; 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR