MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT; LIMB SALVAGE SYSTEM

Model Number BME6616

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Arthralgia (2355); Cancer (3262)

Event Date 06/20/2014

Event Type  Injury  

Event Description

In an email dated (b)(6) 2014, the sales agent contacted the company's design office as requested by the clinician to obtain options for a planned revision of the tibial component on a distal femoral case 1st done on (b)(6) 1991.It was further noted that the patient has a long stem metal tibia component that is causing soreness and needs replacing with either another metal or even an all poly component.

Manufacturer Narrative

The patient was implanted with a custom extra small mets smiles knee.Our records indicate that the patient had a revision in 1999.As the patient is encountering discomfort, the surgeon is contemplating further revision.The company's design department reviewed the patient's recent x-rays and have suggested that the patient undergo a tibial revision with a small mets smiles knee.The physician is currently reviewing the suggested design proposal.A supplemental will be provided upon receipt of follow-up information from the facility.

Manufacturer Narrative

The patient has undergone successful revision surgery for a distal femur.The cause of the revision has been attributed to pain requiring the revision.The reported pain and discomfort could be as a result of patient factors such as trauma, obesity, activity levels, disease progression and/or surgical factors or preferences and not necessarily related to the device itself.There were no reported complications resulting from the revision surgery.This complaint is being closed and is being tracked and trended.

Event Description

In an email dated (b)(6) 2014, the sales agent contacted the company's design office as requested by the clinician, to obtain options for a planned revision of a tibial component on a distal femur case first done on (b)(6) 1991.It was further noted that the patient has a long stem metal tibia component that is causing soreness and needs replacing with either another metal or even an all poly component.This is a supplemental report to 3004105610-2014-002 (b)(4).

• Brand Name: CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD; 210 centennial avenue; centennial park; elstree, WD6 3 SJ; UK WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE LTD; 210 centennial avenue; centennial park; elstree, WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 3954765
• MDR Text Key: 4556551
• Report Number: 3004105610-2014-00002
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/09/1992
• Device Model Number: BME6616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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: 37 YR