MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - TIBIAL COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Loss of Osseointegration (2408); Unintended Movement (3026)

Patient Problems Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2021

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

It has been reported "the patient has aseptic loosening of the tibial component, the tibial component is sinking".

Event Description

It has been reported "the patient has aseptic loosening of the tibial component, the tibial component is sinking".

Manufacturer Narrative

Reported event: an event regarding loosening involving a jts, distal femur 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 jts distal femoral replacement which was inserted on (b)(6) 2014.The surgeon reported tibial piece has sunken.The x-ray images provided show the tibial stem is tilted laterally, and there is larger knee gap between the tibial implant and tibial plateau on the medial side than on the lateral side, but the tibial profile is intact.I think the reason for this to happen is because the epiphyseal plate didn¿t grow evenly (medial side has grown much slower than the lateral side), which lead to uneven of the tibial plateau and tilt of the implant.The tibial stem is loose inside the canal due to growth of the patient.The radiographic review can confirm the 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: on 06oct2021 a discussion was held with a clinical consultant regarding the investigation x ray review, the following was concluded: [.] the loosening and subsidence is likely attributed to bone growth, the reported loosening can be a result of bone growth, which causes the bone canal to increase in size the reported tibial subsidence is associated to the reported loosening, as the bone grows the tibial stem will loosen in situ and shift in position".However, the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, and additional x ray images (post implantation) are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Manufacturer Narrative

Reported event: an event regarding patient factors / loosening involving a jts, distal femur was reported.The event was confirmed by x ray review.Method & results: device evaluation and results: visual inspection: visual inspection of the returned parts shows the distal femoral replacement.Other images showing the product marks are matching to the complaint record.Also, other marks and scratches are noticeable on the part.Additional devices were returned (axle and circlip), visual inspection confirms black bearing marks on the axle and scratches on both parts, however there is no allegation against them in the complaint.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for jts distal femoral replacement which was inserted on (b)(6) 2014.The surgeon reported tibial piece has sunken.The x-ray images provided show the tibial stem is tilted laterally, and there is larger knee gap between the tibial implant and tibial plateau on the medial side than on the lateral side, but the tibial profile is intact.I think the reason for this to happen is because the epiphyseal plate didn¿t grow evenly (medial side has grown much slower than the lateral side), which lead to uneven of the tibial plateau and tilt of the implant.The tibial stem is loose inside the canal due to growth of the patient.The radiographic review can confirm the 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.On (b)(6) 2021 a discussion was held with a clinical consultant regarding the investigation x ray review, the following was concluded: [.] the loosening and subsidence is likely attributed to bone growth, the reported loosening can be a result of bone growth, which causes the bone canal to increase in size.The reported tibial subsidence is associated to the reported loosening, as the bone grows the tibial stem will loosen in situ and shift in position".However, the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, and additional x ray images (post implantation) 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 has been reported "the patient has aseptic loosening of the tibial component, the tibial component is sinking".

• Brand Name: DISTAL FEMUR JTS - TIBIAL 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: 12171721
• MDR Text Key: 261641557
• Report Number: 3004105610-2021-00110
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2023

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: 08/30/2015
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 18463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 11/26/2021; 02/15/2023
• Supplement Dates FDA Received: 12/02/2021; 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2014
• 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: 18 YR
• Patient Sex: Male