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

Catalog Number UNK_STM

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 05/25/2021

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 right proximal tibia with reason for surgery noted: "index surgery was for malignant fibrous histiocytoma right distal femur 2011 has stanmore growing implant." and reason for revision noted: "the tibial stem is loose causing shin pain at the stem tip.".

Manufacturer Narrative

Corrected data: d1.Additional manufacturer narrative: reported event: an event regarding loosening involving a jts, 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: 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 06jan2011.The surgeon reported loosening of the tibial stem.The images provided show that the tibial stem is too small now left a gap between the tibial stem and bone.The original tibial stem was under passive fixation and become too small and loose after ten years due to growth of the bone.Therefore, this 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 was received for the patient's right proximal tibia with reason for surgery noted: "index surgery was for malignant fibrous histiocytoma right distal femur 2011 has stanmore growing implant." and reason for revision noted: "the tibial stem is loose causing shin pain at the stem tip.".

• Brand Name: DISTAL FEMUR JTS - 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
• MDR Report Key: 11997544
• MDR Text Key: 256168159
• Report Number: 3004105610-2021-00089
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2011
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 15838
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23 YR