MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE INTERNAL PROXIMAL FEMORAL REPLACEMENT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNK_STM

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Arthritis (1723); Pain (1994); Injury (2348)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Device is not explanted.

Event Description

A patient specific prescription form was submitted for patient's right femur.Diagnosis is "knee arthritis secondary to trauma".Notes indicate "previous extrusion of femoral cortex with cement into knee joint".

Event Description

A patient specific prescription form was submitted for patient's right femur.Diagnosis is "knee arthritis.Secondary to trauma".Notes indicate "previous extrusion of femoral cortex with cement into knee joint".

Manufacturer Narrative

An event regarding loosening involving a patient specific internal proximal femur was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as no items were provided.Clinician review: "the implant in situ was for a revision of the internal proximal femoral replacement which was inserted on (b)(6) 2012.The surgeon has reported that the stem has an extrusion of the femoral cortex.The x-ray provided shows that the femoral bone wrapping around the proximal stem has disassociated with the component.The distal stem is loose and displaced inside the distal femoral cavity.Therefore, the x- ray review has confirmed the reason for revision".Product history review: review of the product history records indicates 1 device was manufactured and accepted into final stock on 03jul2012 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 28-jun2016 to present for similar reported events regarding loosening involving a patient specific proximal femur.There have been 2 other events.Conclusions: an event regarding loosening involving a patient specific proximal femur was reported.The exact cause of the event could not be determined because further information such as analysis on the retrieval implant, pre- and post-operative x-rays and the primary operative report as well as patient history and follow up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.The reported device is similar to a device approved for compassionate use in the united states.

• Brand Name: INTERNAL PROXIMAL FEMORAL REPLACEMENT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• MDR Report Key: 8810765
• MDR Text Key: 151697172
• Report Number: 3004105610-2019-00096
• Device Sequence Number: 1
• Product Code: JDI
• 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: 10/22/2019

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: Lay User/Patient
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 17189
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR