MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE FEMORAL STEM CURVED LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problems Incorrect Device Or Component Shipped (2962); Packaging Problem (3007)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

The cause of the event has been determined as a missing process step. The following corrective actions have been implemented - device history record release approval work instruction has been updated to include a step to check all routing operations are correct. - the device history record has been updated to include a manufacturing step that gives indication for a curved stem. - the inspection check sheet has been updated to include a check for the missed operation. No further investigation for this event is possible at this time as the device was not returned and insufficient information was received by siw. If devices and / or additional information become available, this investigation will be reopened.

Event Description

It has been reported that a curved stem box was picked but a straight stem was inside.

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. Device not available.

Event Description

It has been reported that a curved stem box was picked but a straight stem was inside.

• Brand Name: FEMORAL STEM CURVED
• 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: 6402199
• MDR Text Key: 195041325
• Report Number: 3004105610-2017-00018
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK_STM
• Device Lot Number: B10211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/04/2017
• 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 Treatment Data

Date Received: 03/14/2017 Patient Sequence Number: 1