MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD EXTENDIBLE DISTAL FEMORAL REPLACEMENT - JTS; LIMB SALVAGE SYSTEM

Model Number PIN 12265

Device Problem Incorrect Device Or Component Shipped (2962)

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

Event Date 10/03/2015

Event Type  malfunction  

Manufacturer Narrative

The surgery was performed with no adverse consequence to the patient.An investigation is being performed in an attempt to identify the cause of the event.(b)(4) has been raised to address this event further.A supplemental will be submitted on completion of the investigation.Device is implanted.

Event Description

It was reported that the general assembly shows that the implant had to be provided in 5 packages: piston & drill guide; femoral assembly; cortical screw; axle; and tibial component.There was a package called piston & drill guide, but there was no piston inside the package.In addition, the pin on the drill guide was etched upside down which was confusing.The femoral assembly package was supposed to contain only 3 components: femoral component, nig shaft body and jts grower assembly.The second package "femoral assembly" had the piston assembled with the above components.These were secured with a temp clip.However, there was no temp clip in the bill of materials.Instructions for the preparation of the cross screw trajectory were provided as page 2 of the operation drawing.These were not consistent with the packages provided which confused both the distributor and the scrub nurse who needed to assemble it.(b)(4).

Manufacturer Narrative

The patient was initially implanted with a custom special total knee replacement.The surgeon diagnosed the patient with a bone infection in (b)(6) 2013 and subsequently the device was explanted.The surgeon opted for a mets device to be implanted as the first stage of a two stage revision.The surgeon ordered a custom distal femur for the second stage of the revision, the procedure was successfully carried out on (b)(6) 2015.Device evaluation could not be performed as the product was discarded.Medical records were not returned to allow the root cause of the infection to be established.Dhr review for the reported lot determined that the device was manufactured and packed to specification.Infection is a procedure-related aspect of arthroplasty with sometimes additional patient-related risk factors for infection and is not necessarily related to the device.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, product return, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Stanmore will continue to monitor for trends.

Event Description

The patient was diagnosed with a bone infection in (b)(6) 2013 and the custom special total knee replacement implant in situ at the time was explanted.A two stage revision was planned in (b)(6) 2013, the first stage of the revision required the patient to be implanted with a mets smiles total knee replacement device and being treated for infection.The surgeon ordered a custom distal femur replacement implant for the patient's second stage revision on (b)(6) 2015.This second stage revision was successfully performed on (b)(6) 2015.This is a supplemental report to 3004105610-2015-00106 ((b)(4)).

Event Description

It was reported that the general assembly shows that the implant had to be provided in 5 packages: 1) piston and drill guide; 2) femoral assembly; 3) cortical screw; 4) axle; and 5) tibial component.There was a package called piston and drill guide, but there was no piston inside the package.In addition, the pin on the drill guide was etched upside down which was confusing.The femoral assembly package was supposed to contain only 3 components: femoral component, nig shaft body and jts grower assembly.The second package "femoral assembly" had the piston assembled with the above components.These were secured with a temp clip.However, there was no temp clip in the bill of materials.Instructions for the preparation of the cross screw trajectory were provided as page 2 of the operation drawing.These were not consistent with the packages provided which confused both the distributor and the scrub nurse who needed to assemble it.This is a supplemental report to 3004105610-2016-00106 ((b)(4)).

• Brand Name: EXTENDIBLE DISTAL FEMORAL REPLACEMENT - JTS
• 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, WD6 3-SJ ; UK WD6 3SJ ; 208238 650
• MDR Report Key: 6092001
• MDR Text Key: 59851290
• Report Number: 3004105610-2016-00106
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K12133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/12/2017
• Device Model Number: PIN 12265
• Device Lot Number: PIN 20373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2016
• 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: 4 YR