MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE JTS TOTAL FEMUR; LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem Failure of Implant (1924)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

As reported in the bone & joint journal article "comparison of minimally invasive systems in lengthening total femoral prostheses", a retrospective review determined that 2 non-invasive grower constructs were revised due to failure to lengthen.

• Brand Name: JTS TOTAL FEMUR
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8211774
• MDR Text Key: 131892231
• Report Number: 3004105610-2019-00004
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K092138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2018
• 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 Outcome(s): Hospitalization