MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK EMBRACE SHOULDER SYSTEM; MODULAR STEM, TI6AL4V CEMENTED/ CEMENTLESS, L= 75 MM, Ø 14 MM

Model Number	641-075/14
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Damaged Prior to Receipt by User (1570); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Damaged inner sterile bag.[customer].
Additional Manufacturer Narrative
The review of the device history records showed no deviation.This is the final supplemental report, the complaint is closed.
Event or Problem Description
Damaged inner sterile bag.[customer].

• Brand Name: LINK EMBRACE SHOULDER SYSTEM
• Common Device Name: MODULAR STEM, TI6AL4V CEMENTED/ CEMENTLESS, L= 75 MM, Ø 14 MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 21354343
• Report Number: 3004371426-2025-00005
• Device Sequence Number: 21113927
• Product Code: PHX
• UDI-Device Identifier: 04026575234455
• UDI-Public: 04026575234455
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K212992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/29/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: 641-075/14
• Device Catalogue Number: 641-075/14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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
• Patient Sex: Unknown