MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE SMILES KNEE BUSHES SMALL; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number SMBSH01

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2021

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

A patient specific prescription form was received for the patient's left distal femur with reason for surgery stating: "failed components - failure of bushes." other notes indicate: "please supply a cemented over distal femoral component to couple with existing tibial implant.".

Manufacturer Narrative

Additional manufacturer narrative reported event: an event regarding re-bushing involving a jts, distal femur, bushing was reported.The event was not confirmed.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 2005 and revised on (b)(6) 2012.The surgeon reported failure of the femoral component and failure of the bushes.The x-ray images provided show that the implant is well fixed, apart from the radiolucent line between the cement mantle and bone on anterior tibia, and the femoral component is well aligned with the tibial component.The fixed hinge knee is in place and the failure of the bushes cannot be observed from the images provided.Therefore, the radiographic review cannot confirm the clinical report and reason for revision, but it may be assessable and justified from clinical symptoms.Device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.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.

Event Description

A patient specific prescription form was received for the patient's left distal femur with reason for surgery stating: "failed components - failure of bushes." other notes indicate: "please supply a cemented over distal femoral component to couple with existing [tibial] implant." update (b)(6) 2021 - x ray review: "[.] the x-ray images provided show that the implant is well fixed, apart from the radiolucent line between the cement mantle and bone on anterior tibia.".

• Brand Name: SMILES KNEE BUSHES SMALL
• 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: 11928679
• MDR Text Key: 254006577
• Report Number: 3004105610-2021-00081
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K133152
• 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: 09/09/2021

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: 08/31/2017
• Device Catalogue Number: SMBSH01
• Device Lot Number: B9076
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 08/31/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR