MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD. CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT; LIMB SPARING SYSTEM

Model Number BME 19481

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Cancer (3262)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

It was reported to the company sales representative that the delivery advice notice stated that the device was sterile and no irradiation was required.However, the custom device was provided non-sterile as ordered.The outer plastic wrapping on the device correctly identified the device as non-sterile.The theatre stores team identified this prior to the device being sent to the theatre.The device underwent the hospital's off-sire sterilization process and was available for the scheduled procedure.The procedure was completed successfully as scheduled.

Manufacturer Narrative

The manufacturing history records have been reviewed and confirmed that the device was manufactured within spec with no abnormalities or deviations.This custom order was for a non-sterile device.A review of the delivery note accompanying the device confirmed that it incorrectly specified that the custom device was sterile and that no irradiation was required as per the reported complaint.However, the custom device was provided as ordered (non-sterile) and correctly labeled as non-sterile.The delivery note is generated by customer services and is reviewed and signed by a member of the design team.Both teams have undergone awareness training of the complaint.A review of the complaints history for the previous 24 months identifies no similar reported complaints.Please note that this custom implant is similar to the mets modular proximal femur implant (k121056).

• Brand Name: CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT
• Type of Device: LIMB SPARING SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD.; elstree WD6 3SJ; UK WD6 3SJ
• Manufacturer Contact: sian rogers ; elstree WD6 3-SJ ; UK WD6 3SJ ; 082386500
• MDR Report Key: 4898335
• MDR Text Key: 6831746
• Report Number: 3004105610-2015-00059
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2015
• Device Model Number: BME 19481
• Device Lot Number: BME 19481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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): Other
• Patient Age: 50 YR