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

Catalog Number UNK_STM

Device Problem Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); Cancer (3262)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.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.Device not returned.

Event Description

A patient specific prescription form was received for the patient's left proximal tibia.Reason for surgery indicates: "ewing sarcoma last revised 1996" and reason for revision indicates: "aseptic loosening." form also indicates "full revision.Rotating hinge.Ha collar.".

Event Description

A patient specific prescription form was received for the patient's left proximal tibia.Reason for surgery indicates: "ewing sarcoma last revised 1996" and reason for revision indicates: "aseptic loosening." form also indicates "full revision, rotating hinge, ha collar.".

Manufacturer Narrative

Reported event: an event regarding loosening involving a patient specific, proximal tibia, 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 a proximal tibial replacement which was inserted on (b)(6) 1996.The surgeon reported an aseptic loosening of the stem.The image provided shows massive radiolucent lines along the stem between the cement mantle and cortical bone.There are significant bone resorption and osteolytic lesion which left a thin cortex in general.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate (b)(4) device was manufactured and accepted into final stock on 08 oct 1996 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, 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.

• 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: 11140421
• MDR Text Key: 225785566
• Report Number: 3004105610-2021-00004
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/1997
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 4459
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR