MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE BAYLEYWALKER GLEN COMP EXT SML; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number WBGC00

Device Problems Positioning Problem (3009); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.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.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.Device not returned.

Event Description

The surgeon was doing a linked glenoid bailey walker replacement of a left humerus.When trying to relocate the head on the glenoid to the humeral head; the glenoid component pulled out of the bone.The surgeon was advised of on-label options; converting to a hemi, or changing the glenoid component to a larger component.The surgeon had checked the glenoid sizing twice when preparing the glenoid & decided to keep the same sized component in situ.The surgeon put the threaded component back in the glenoid & put an immobilization sling on.The surgeon didn¿t want to exchange any of the components, after doing an x-ray.Left shoulder surgical delay of less than 5 minutes.

Manufacturer Narrative

Reported event: an event regarding intraoperative loosening involving a glenoid screw of a mets proximal humerus was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as product remained implanted.Clinician review: the image provided shows that there is a gap between the collar of the glenoid component and the glenoid bone which confirms the clinical report.This could be due to the porosity of the glenoid bone that affects the fixation of the glenoid implant.Product history review: review of the product history records indicate (b)(4) were manufactured and accepted into final stock on (b)(6) 2019 with no reported discrepancies.Complaint history review: there have been no other similar events.Conclusions: an event regarding intraoperative loosening involving a glenoid screw of a mets proximal humerus was reported.The event was confirmed by medical review.It was reported that the surgeon was advised of on-label options; however, he decided to keep the same sized component in situ.The surgeon then put the threaded component back in the glenoid and put an immobilisation sling on.It was reported that the surgeon didn¿t want to exchange any of the components, after doing an x-ray.A surgical delay of less than 5 minutes was reported.The clinical review suggested that this could be due to the porosity of the glenoid bone that affects the fixation of the glenoid implant.However, the exact cause of the event could not be determined.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.

Event Description

The surgeon was doing a linked glenoid bailey walker replacement of a left humerus.When trying to relocate the head on the glenoid to the humeral head; the glenoid component pulled out of the bone.The surgeon was advised of on-label options; converting to a hemi, or changing the glenoid component to a larger component.The surgeon had checked the glenoid sizing twice when preparing the glenoid & decided to keep the same sized component in situ.The surgeon put the threaded component back in the glenoid & put an immobilization sling on.The surgeon didn't want to exchange any of the components, after doing an x-ray.Left shoulder surgical delay of less than 5 minutes.

• Brand Name: BAYLEYWALKER GLEN COMP EXT SML
• 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
• MDR Report Key: 10730983
• MDR Text Key: 213223317
• Report Number: 3004105610-2020-00172
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WBGC00
• Device Lot Number: B24662
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 80