MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD. CUSTOM DISTAL FEMUR IMPLANT

Model Number BME18630

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2014

Event Type  malfunction  

Event Description

It was reported by the surgeon that the delivery of the distal femur replacement implant did not contain the bumper pad.

Manufacturer Narrative

A review of the manufacturing history confirms no non-conformances were identified.Review of the order details and the shipping details confirms that the bumper pad was pre-assembled with the implant and therefore was not missing.This was communicated to the surgeon and the device was implanted successfully with no further complaints reported.Please note that this custom implant is similar to the mets modular distal femur replacement implant (k121029).

• Brand Name: CUSTOM DISTAL FEMUR IMPLANT
• Type of Device: DISTAL FEMUR IMPLANT
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD.; elstree, hertfordshire ; UK
• Manufacturer Contact: sian rogers ; 210 centennial ave., centennial park; elstree WD63S-J ; UK WD63SJ ; 082386500
• MDR Report Key: 4373069
• MDR Text Key: 15109170
• Report Number: 3004105610-2014-00174
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2014
• Device Model Number: BME18630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: 28 YR