MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG SPII MODEL LUBINUS; HIP PROSTHESIS STEM XL NECK, CEMENTED, L= 150 MM, LEFT L3, LARGE, CCD 126°, COCR

Model Number	127-767/26
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Incorrect device laser markings of a spii model lubinus hip stems with the article ref 127-767/26.[customer].
Additional Manufacturer Narrative
A field safety corrective action r-2026-03 was started in the form of field safety notice and recall.Furthermore a capa was initiated to determine further corrective and preventive action.There are no affected devices on the us market.
Additional Manufacturer Narrative
The production records have been inspected and reviewed.A field safety corrective action r-2026-03 was started in the form of field safety notice and recall.Furthermore a capa was initiated to determine further corrective and preventive action.There are no affected devices on the us market.This is the final supplemental report, the complaint is closed.
Event or Problem Description
Incorrect device laser markings of a spii model lubinus hip stems with the article ref 127-767/26.[customer].

• Brand Name: SPII MODEL LUBINUS
• Common Device Name: HIP PROSTHESIS STEM XL NECK, CEMENTED, L= 150 MM, LEFT L3, LARGE, CCD 126°, COCR
• 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: 24301933
• Report Number: 3004371426-2026-00010
• Device Sequence Number: 5381379
• Product Code: JDG
• UDI-Device Identifier: 04026575241484
• UDI-Public: 04026575241484
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 127-767/26
• Device Catalogue Number: 127-767/26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• 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