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

Lot Number PIN 1471

Device Problem Naturally Worn (2988)

Patient Problem Cancer (3262)

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

It is reported by a surgeon that the patient underwent a primary distal femur endoprosthetic replacement procedure for the treatment of osteosarcoma in 1989.The patient subsequently underwent rebushing in 2005.The patient's current surgeon is requesting implant specific information as he is considering his options, i.E., perform a rebushing revision procedure (replace the plastic bearing components), or replace the in situ implant.

• Brand Name: DISTAL FEMUR
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD; 210 centennial avenue; centennial park; elstree, hertfordshire WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park; elstree, hertfordshire WD6 3-SJ ; UK WD6 3SJ
• MDR Report Key: 6252831
• MDR Text Key: 241361510
• Report Number: 3004105610-2016-00040
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: PIN 1471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/1989
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female