MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE SMILES KNEE AXLE CAP EXSM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number SMCAP01

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Ambulation Difficulties (2544)

Event Date 12/15/2020

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 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.

Event Description

It was reported that the patient's right knee, which was "operated in 2014 had flexion problems as a result of bumper insert fracture." as reported by a senior staff engineer, "by looking at the pictures, it looks to me that the axle is backed out.".

Manufacturer Narrative

Additional manufacturer narrative reported event: an event regarding backing out involving a jts, distal femur, axle caps was reported.The event was confirmed by x ray review.Method & results: 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 jts distal femoral replacement which was inserted in 2014.The surgeon reported that the patient had knee flexion issue.One of the senior staff engineers reported that the axle backed out and possible bumper fracture.The image provided shows that the axle has backed out laterally and the femoral component was disengaged with the tibial hinge, but the bumper fracture cannot be clearly observed although some debris in the knee joint may indicate fracture or wear of the bumper.The above radiographic observation maybe able to explain the clinical problem of the knee flexion.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate 100 devices were manufactured and accepted into final stock on 19 june 2013 with no reported discrepancies.Complaint history review: lot id: b11938.There has been 1 other relevant event.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, x-rays 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.

Event Description

It was reported that the patient's right knee, which was "operated in 2014 had flexion problems as a result of bumper insert fracture." as reported by a senior staff engineer, "by looking at the pictures, it looks to me that the axle is backed out.".

• Brand Name: SMILES KNEE AXLE CAP EXSM
• 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 Key: 11129514
• MDR Text Key: 225490204
• Report Number: 3004105610-2021-00002
• 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: 02/24/2021

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: 06/30/2018
• Device Catalogue Number: SMCAP01
• Device Lot Number: B11938
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 13 YR