MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 09/07/2020

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.Catalog numbers and lot codes of other devices listed in this report: smcic01 smiles knee circlip mk2, lot b5399.Smbsh02 smiles knee bushes standard, lot b5033.Smbpr02 smiles knee bumpers standard, lot b5034.Smmltb02 short tibial bearing mk4 - std, lot b5029.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Reason for revision: infected epr prox tibia, post first stage, septic loosening.

Manufacturer Narrative

Reported event: an event regarding infection involving a patient specific, proximal tibia was reported.The event was not confirmed.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 proximal tibial replacement which was inserted on (b)(6) 2008.The surgeon reported infection and septic loosening of the implant.The x-rays provided show that the original implant has been removed and femoral and tibial metal nails were in place.There is periprosthetic fracture on the medial side mid-shaft of the femur, but rest of the femoral bone is in good condition.The posterior side of the tibial bone has some defects near the resection otherwise the rest of the bone is in good condition.No sign of the infection can be observed through the radiographic images and the septic loosening of the implant cannot be confirmed due to removal of the implant.Device history review: review of the product history records indicate 1 devices were manufactured and accepted into final stock on the 14th of april 2008 with no reported discrepancies.Complaint history review: there have been 6 other events.Conclusion: the surgeon reported infection and septic loosening of the implant.The x-rays provided show that the original implant has been removed and femoral and tibial metal nails were in place, no signs of infection can be observed through the radiographic images and the septic loosening of the implant cannot be confirmed due to removal of the implant.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

Reason for revision: infected epr prox tibia, post first stage, septic loosening.Update 19nov2020: x-ray review : " the x-rays provided show that the original implant has been removed and femoral and tibial metal nails were in place.There is periprosthetic fracture on the medial side mid-shaft of the femur, but the rest of the femoral bone is in good condition".

• Brand Name: PROXIMAL TIBIA
• 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: 10619113
• MDR Text Key: 209556908
• Report Number: 3004105610-2020-00152
• 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
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2008
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 13699
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention