MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE HUMERAL BEARING LINER SELF CA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number HBLSC

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 05/31/2023

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.H3 other text : device remains implanted.

Event Description

This pi is for the impending revision of the patient's left shoulder (self-captive liner).A patient-specific implant request form was received for the patient's left bayley-walker shoulder.Noted on the form: "bayley-walker tsa performed 8 years ago.Fell in february landing on the left elbow with axial compression of the shoulder.A periprosthetic scapular fracture with superior angulation of the glenoid screw and dislocation of the prosthesis diagnosed.Scapular fracture realigned and fixed, now healed.The shoulder replacement is located but the liner was noted to be worn and allowed easy lateral displacement of the humerus from the glenoid screw.The liner needs replacing as a second stage.Rehabilitation is not favoured by the present lack of captivity.Hence the request for a replacement self-captive liner.".

• Brand Name: HUMERAL BEARING LINER SELF CA
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17190045
• MDR Text Key: 317731843
• Report Number: 3004105610-2023-00066
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: HBLSC
• Device Lot Number: B12762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2014
• 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; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female