MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) - TIBIAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

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

Patient Problem Inadequate Osseointegration (2646)

Event Date 08/01/2022

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 loosening involving a mig, distal femoral replacement, tibial stem 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: the implant in situ was for mig distal femoral replacement, in which the original implant was inserted on (b)(6) 1999 and subsequently revised several times.The surgeon reported unstable implant.The ct image provided shows radiolucent lines along the femoral and tibial stems mainly between the cement mantle and stem.Especially for tibial stem, aseptic loosening of the stem can be expected which may explain unstable implant.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate the device was 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 has been received.Noted on the form " revision of extended implant.Previous grower well fixed proximal stem.Extra small femur to cement over current stem to create definitive implant.Also need an extra small metal cased rotation hinge tibial component please.Previous osteosarcoma now unstable implant." update 28 oct 2022: clinical review confirms the following: " [.] the ct image provided shows radiolucent lines along the femoral and tibial stems mainly between the cement mantle and stem.Especially for tibial stem, aseptic loosening of the stem can be expected which may be explain unstable implant [.]".This mdr is for the tibial stem.

• Brand Name: DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) - TIBIAL STEM
• 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: 15758280
• MDR Text Key: 303295426
• Report Number: 3004105610-2022-00153
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2005
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 11821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female