MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE TIBIAL COMPONENT FIXED HINGE LIMB SALVAGE SYSTEM

Model Number MKFH/STDLG

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

While the device was incorrectly labelled on the outside the was no risk to patient as the device was correctly labelled on the inside and the error was identified prior to surgery. On completion of the investigation into the reported event it can be concluded that the incident does not meet the three basic reporting criteria referenced in 21 cfr part 803 as a marketed device did not cause or contribute to a death or serious injury, or a marketed device has not malfunctioned where the malfunction of the device or a similar marketed device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Product surveillance will continue to monitor for trends.

Event Description

It has been reported that when the customer received a tibial fixed hinge assembly, the label was green in colour when it should have been red. The issue was noticed during a stock check, there were no patient adverse consequences for this event.

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event. Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.

Event Description

It has been reported that when the customer received a tibial fixed hinge assembly, the label was green in colour when it should have been red. The issue was noticed during a stock check, there were no patient adverse consequences for this event.

• Brand Name: TIBIAL COMPONENT FIXED HINGE
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 6864787
• MDR Text Key: 246032431
• Report Number: 3004105610-2017-00065
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K121029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2020
• Device Model Number: MKFH/STDLG
• Device Catalogue Number: UNK_STM
• Device Lot Number: A12273/Z6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial