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

Catalog Number UNK_STM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Joint Dislocation (2374); Cancer (3262)

Event Date 01/10/2017

Event Type  Injury  

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 returned.

Event Description

It was reported that the patient has a dislocation and perforation of the acetabula following a total femoral replacement.

Manufacturer Narrative

An event regarding perforation of the acetabulum and dislocation of a jts total femur head was reported.The event was confirmed by x-ray.A device history review identified no relevant reported discrepancies.Conclusions: the review of the device history records (including dispatch documentation, labelling and operation drawing) indicates that a femoral head was not requested or supplied with the device (pin 20219).As such there is no indication that the reported perforation / wear of the patient's acetabulum and the dislocated femoral head is related to a stanmore implants device.It is reported that the surgeon did not ream the acetabulum when implanting pin 20219.Reaming of a not yet formed acetabulum would have increased the joint stability as it would provide more cover to the femoral head.The failure to ream the acetabulum resulted in instability and is the most likely cause of the patient's acetabular wear and dislocation.The surgeon requested a custom revision acetabular cup in (b)(6) 2017 in order to perform a revision procedure.The design of the revision device has been placed on hold and the surgeon has not confirmed his treatment plan for the patient.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, the investigation into this event will be reopened.

Event Description

It was reported that the patient has a dislocation and perforation of the acetabula following a total femoral replacement.

• Brand Name: TOTAL FEMUR JTS
• 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: 6348614
• MDR Text Key: 67924352
• Report Number: 3004105610-2017-00013
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/16/2017
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 20219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2016
• 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): Required Intervention
• Patient Age: 9 YR