MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD CUSTOM JTS NON-INVASIVE DISTAL FEMORAL IMPLANT; LIMB SALVAGE SYSTEM

Model Number BME17178

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problems Unspecified Infection (1930); Cancer (3262)

Event Date 11/01/2012

Event Type  malfunction  

Event Description

It was reported by the surgeon that during a distal femur replacement procedure that the collar on the uncemented reamer was assembled incorrectly.This was rectified on removal from the sterile packaging.Reaming of the femoral canal was then performed with no concerns raised.

Manufacturer Narrative

The device is inspected and cleaned in parts and then assembled in the clean room following the wash process.The assembled device is then inspected by the design team before release to a sub contractor for the irradiation process.The mfg records were reviewed and no non-conformances were identified, therefore, it is assumed that the device left siw conforming.It is not possible to identify when or where this device was altered.The device has not been returned, therefore, a visual inspection has not been possible.Current info is insufficient to permit a conclusion as to the cause of the reported event.Requests are being made for additional 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 distal femur implant (k121056).

Manufacturer Narrative

In 2012 the device was inspected, cleaned in parts and then assembled in the clean room following the wash process.The assembled device was then inspected by the design team before release to a sub-contractor for the irradiation process.The manufacturing records were reviewed and no non-conformances were identified, therefore it is assumed that the device left siw conforming.It is not possible to identify when or where this device was altered.The device has not been returned; therefore a visual inspection has not been possible.Current information available is insufficient to permit a conclusion for the cause of the reported event.The current day product release process now includes a final visual inspection and a review of the dhr by quality assurance to help ensure that the correct components in the correct configuration are shipped out.The design proposal and operation drawing provided for the surgeon ensures that the surgeon is informed of the configuration of the implant components.This complaint is being closed and is being tracked and trended.

Event Description

It was reported by the surgeon that during a distal femur replacement procedure that the collar on the uncemented reamer was assembled incorrectly.This was rectified on removal from the sterile packaging.Reaming of the femoral canal was then performed with no concerns raised.This is a supplemental report to 3004105610-2014-00119 (b)(4).

Manufacturer Narrative

Review of the device history record confirms that the product was shipped to specification.Based on a review of the provided x-ray information, the reported tibial stem loosening was confirmed.There is no indication that the observed stem loosening was device related as no device or manufacturing related issues have been identified.It is noted that the tibial stem has, by design, a sliding fit within the medullary canal to allow growth of the proximal tibial bone.The device did not reach maximum extension, but had aseptically loosened.The cause of the failure could not be determined, though aseptic loosening was confirmed through the scan review.Aseptic loosening is a well-known complication for orthopaedic implants which can occur early or late.There were no reported complications with the revision surgery.This complaint is being closed, and is being tracked and trended.

Event Description

It was reported by the surgeon that the patient underwent a primary procedure to implant a noninvasive extendible distal femur implant on (b)(6) 2009 and subsequently was revised on (b)(6) 2012 due to the prosthesis reaching full extension.The patient is also reporting pain.This is a final supplemental report for 3004105610-201400119 (b)(4).

• Brand Name: CUSTOM JTS NON-INVASIVE DISTAL FEMORAL 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: 4390405
• MDR Text Key: 21773962
• Report Number: 3004105610-2014-00119
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2012

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2012
• Device Model Number: BME17178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2012
• 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: 8 YR