MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG PROSTHESIS HEADS B; PROSTHESIS HEAD B, Ø 32 MM, NECK L= S, - 4 MM, TAPER 12/14, COCRMO

Model Number	128-832/01
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the device history record 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.
Event or Problem Description
Defect in sealed seam of the outer sterile pouch [customer].
Event or Problem Description
Defect in sealed seam of the outer sterile pouch [customer].
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

• Brand Name: PROSTHESIS HEADS B
• Common Device Name: PROSTHESIS HEAD B, Ø 32 MM, NECK L= S, - 4 MM, TAPER 12/14, COCRMO
• 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: 25041903
• Report Number: 3004371426-2026-00030
• Device Sequence Number: 18536861
• Product Code: JDG
• UDI-Device Identifier: 04026575365166
• UDI-Public: 04026575365166
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K953653
• 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): 04/07/2026

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 Model Number: 128-832/01
• Device Catalogue Number: 128-832/01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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