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

Catalog Number UNK_STM

Device Problems Break (1069); Fracture (1260)

Patient Problem Injury (2348)

Event Date 09/09/2019

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.

Event Description

A patient specific prescription form was submitted for patient's right distal femur.Diagnosis is "right dfr fracture".Note indicate "(nickel free) custom dfr, fracture though clip/axle loose/broken".

Event Description

A patient specific prescription form was submitted for patient's right distal femur.Diagnosis is "right dfr fracture".Note indicate "(nickel free) custom dfr, fracture though clip/ axle loose / broken".

Manufacturer Narrative

On 06sep2019 notification of a fractured device pin 21506 was logged as (b)(4) and reported to the fda under ref 3004105610-2019-00108 on 03oct2019.On 21oct2019 an email was received discussing the revision case and was logged as (b)(4) and reported to the fda under ref 3004105610-2019-00115 on 23oct2019.Since both pi¿s investigate a fracture of pin 21506, (b)(4) will be closed as duplicate of (b)(4).

• 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: 9224895
• MDR Text Key: 164120942
• Report Number: 3004105610-2019-00115
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• 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 21506
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR