MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK EMBRACE SHOULDER SYSTEM

Model Number	643-042/16
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Event or Problem Description
The embrace shoulder system was implanted on (b)(6) 2024 in a revision situation.The prior device was another manufacturer's.The surgeon reports that this multiple revised patient has experienced disassociation of the poly/dislocation, and has experienced this before with the prior (non-link) device also.The surgeon is unsure why this patient is dislocating, but suspects the patient is having some impingement that levers out the poly.Revision surgery is planned, with a custom device.

• Brand Name: LINK EMBRACE SHOULDER SYSTEM
• Common Device Name: LINK EMBRACE SHOULDER SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 23405212
• Report Number: 3006721341-2025-00018
• Device Sequence Number: 20065456
• Product Code: HSD
• UDI-Device Identifier: 04026575238545
• UDI-Public: (01)04026575238545(17)26033(10)2106016
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025
• Report Date (Section F): 10/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: 643-042/16
• Device Catalogue Number: 643-042/16
• Device Lot Number: 2106016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2025
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 10/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 127 KG