MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG EMBRACE; REVERSE TRAY, COCRMO NEUTRAL

Model Number	643-010/00
Medical Device Problem Codes	Unintended Movement (3026); Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Loosening of the reverse tray.
Additional Manufacturer Narrative
The review of the device history showed no deviations.The product complies with the specifications valid at the time of manufacture.
Event or Problem Description
Loosening of the reverse tray.
Additional Manufacturer Narrative
The review of the device history showed no deviations.The product complies with the specifications valid at the time of manufacture.This is the final supplemental report, the complaint is closed.

• Brand Name: EMBRACE
• Common Device Name: REVERSE TRAY, COCRMO NEUTRAL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 21446446
• Report Number: 3004371426-2025-00009
• Device Sequence Number: 12703045
• Product Code: PAO
• UDI-Device Identifier: 04026575237029
• UDI-Public: 04026575237029
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 643-010/00
• Device Catalogue Number: 643-010/00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male