MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE CUSTOM GLENOID SHELL AND STEM; LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930); Injury (2348); Joint Dislocation (2374)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

The suspect device is a patient specific proximal humerus implant which is similar to a patient specific proximal humerus approved in the united states for compassionate use.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.Device not returned.

Event Description

As reported: ".We proceeded with cad cam shoulder arthroplasty in (b)(6) 2017, this was complicated with early dislocation and quite unusual early soft tissue reaction, overgrowth in tissues and also by staph epidermidis infection and several debridements.".

• Brand Name: CUSTOM GLENOID SHELL AND STEM
• 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: margaret foley ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 8000288
• MDR Text Key: 124856916
• Report Number: 3004105610-2018-00106
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/30/2017
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 20356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2017
• 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
• Treatment: WBGCP28-38, B/W GLENOID CUP 28/38, STM LOT B13392; WBGCP28-38, B/W GLENOID CUP 28/38, STM LOT B15989; WBGCP32-42, B/W GLENOID CUP 32/42, STM LOT B16497
• Patient Outcome(s): Hospitalization; Required Intervention