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

Model Number BME17746

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problems No Known Impact Or Consequence To Patient (2692); Cancer (3262)

Event Date 05/08/2013

Event Type  malfunction  

Event Description

It was reported by the surgeon that the custom device that was designed and supplied for this pt was supplied with a medical plate, which had not been preapproved by the surgeon.

Manufacturer Narrative

A review of the device history was performed and no non-conformances were identified with the devices.The surgeon had no other issues with the components that were provided and was able to complete the procedure as he had planned.Requests are being made for add'l info and a supplemental report will be provided if this info is received.Please note that this custom implant is similar to the mets modular proximal femur implant (k121056).

• Brand Name: CUSTOM PROXIMAL FEMUR IMPLANT
• Type of Device: PROXIMAL 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: 4373398
• MDR Text Key: 5112144
• Report Number: 3004105610-2014-00144
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• 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: 05/08/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2013
• Device Model Number: BME17746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 16 YR