MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE UNKNOWN DISTAL FEMORAL REPLACEMENT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Unstable (1667); Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Injury (2348); Inadequate Osseointegration (2646); Cancer (3262)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: smiles knee circlip mk2; cat# smcic01; lot# b14331, smiles knee bushes standard; cat# smbsh02; lot# b9353, smiles knee bumpers standard; cat# smbpr02; lot# b11272.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

Event Description

The sales representative reported that: "this is a revision of a distal femoral replacement implanted in 2017 (pin (b)(4)).In 2017 the surgeon decided to do a ¿simple¿ distal femoral replacement with no growing mechanism for the patient, as the prognosis for this patient was not good.Now the patient's health has improved the surgeon would like to revise the implant to a distal femoral jts implant to compensate the leg length discrepancy.The tibial component will remain in situ.

Event Description

The sales representative reported that : "this is a revision of a distal femoral replacement implanted in 2017 (pin 20398).In 2017 the surgeon decided to do a ¿simple¿ distal femoral replacement with no growing mechanism for the patient, as the prognosis for this patient was not good.Now the patient's health has improved the surgeon would like to revise the implant to a distal femoral jts implant to compensate the leg length discrepancy.The tibial component will remain in situ.

Manufacturer Narrative

Corrected data.D2 from kwl to kro.D2 from prosthesis, hip, hemi-, femoral, metal to prosthesis, knee, femorotibial, constrained, cemented, metal/polymer.Additional manufacturer narrative.Reported event: an event regarding infection involving a patient specific, distal femur, was reported.The event was confirmed by x-ray review.Device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for a distal femoral replacement which was inserted on (b)(6) 2017.Surgeon reported that the patient had implant infection but cleared after treatment, instability of the femoral implant and leg length discrepancy.Ct scan provided showed massive radiolucent lines around the femoral stem, with severe bone defects and osteolysis that could be caused by previous infection.On the lateral view of the image, the bone has fractured at the tip of the stem.All these defects observed can lead to loosening and instability of the stem.Because the ct scan only showed the affected leg, the leg length discrepancy cannot be assessed.Therefore, the radiographic assessment can confirm the reason for revision.Device history review: review of the product history records indicate (b)(4) devices was manufactured and accepted into final stock on 11 jan 2017 with no reported discrepancies.Complaint history review: there have been 4 other events.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes, and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: UNKNOWN DISTAL FEMORAL REPLACEMENT
• 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: 9853177
• MDR Text Key: 188840550
• Report Number: 3004105610-2020-00067
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K140898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

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 Expiration Date: 06/30/2017
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 20398
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 YR