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

Catalog Number UNK_STM

Device Problem Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646); Cancer (3262)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Device not returned.

Event Description

A patient specific prescription form was received with diagnosis "aseptic loosening, [distal] femoral stem" and note "need to revise fixed hinge to rotating hinge.".

Manufacturer Narrative

Reported event: an event regarding loosening of a femoral stem involving a patient specific distal femoral replacement was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as no items were returned.Clinician review: a review of the provided x-rays by clinical consultant indicated: the implant in situ was for a distal femoral replacement which was inserted on (b)(6) 1990.The surgeon reported loosening of the stem.The x-ray provided shows massive bone resorption and osteolytic lesion.Some radiolucent lines can be observed especially near the bone resection.Therefore, the radiographic review can confirm the reason for revision.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 08mar1990 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01jan2017 to present for similar reported events regarding loosening of femoral stem in patient specific distal femur.There have been 6 other events.Conclusions: an event regarding loosening of a femoral stem involving a patient specific distal femoral replacement was reported.The event was confirmed by medical review.Our records show that the implant was implanted 30 years ago.The exact cause of the event could not be determined because 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.

Event Description

A patient specific prescription form was received with diagnosis "aseptic loosening, [distal] femoral stem" and note "need to revise fixed hinge to rotating hinge.".

• Brand Name: DISTAL FEMUR
• 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; GB WD6 3SJ
• MDR Report Key: 9817347
• MDR Text Key: 183781859
• Report Number: 3004105610-2020-00057
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K140898
• 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: 04/17/2020

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 Catalogue Number: UNK_STM
• Device Lot Number: PIN 1617
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR