MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LUBINUS SPII HIP PROSTHESIS SYSTEM; SP II LONG PROSTHESIS STEMS, RIGHT COCRMO, MEDIUM, STEM-L. 250 CCD <) 135°, TAP

Model Number	127-922/35
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Periprosthetic fracture (4902)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Fracture of the prosthesis stem [customer].
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specification valid at the time of manufacture.This is the final supplemental report, the complaint is closed.
Event or Problem Description
Fracture of the prosthesis stem [customer].

• Brand Name: LUBINUS SPII HIP PROSTHESIS SYSTEM
• Common Device Name: SP II LONG PROSTHESIS STEMS, RIGHT COCRMO, MEDIUM, STEM-L. 250 CCD <) 135°, TAP
• 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: 19475314
• Report Number: 3004371426-2024-00041
• Device Sequence Number: 4071821
• Product Code: JDG
• UDI-Device Identifier: 04026575025244
• UDI-Public: 04026575025244
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K953653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted 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): 05/22/2024

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 Expiration Date: 02/26/2025
• Device Model Number: 127-922/35
• Device Catalogue Number: 127-922/35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown