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

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.

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.

• 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: 69917750
• 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: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: B10211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Sequence Number: 1
• Patient Outcome(s): Other