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

Catalog Number UNK_STM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

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. Reported event: an event regarding periprosthetic fracture involving a patient specific, proximal tibia, 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 medical records and/or x-rays by a clinical consultant indicated: the implant in situ was for proximal tibial replacement which was inserted on 17apr2008. 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 14mar2008 with no reported discrepancies. Complaint history review: there have been no other relevant 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, 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 (b)(6) 2020: 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 - FEMORAL COMPONENT
• 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
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 11001581
• MDR Text Key: 221215695
• Report Number: 3004105610-2020-00192
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2008
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 13699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/14/2020 Patient Sequence Number: 1