MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MP RECONSTRUCTION SYSTEM; HIP PROSTHESIS STEM, UNCEMENTED, L= 210 MM, Ø 20 MM, T

Model Number	172-921/20
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Fracture of hip stem [customer].
Additional Manufacturer Narrative
The production records have been inspected and reviewed.Additional steps have been taken to release the product.

• Brand Name: MP RECONSTRUCTION SYSTEM
• Common Device Name: HIP PROSTHESIS STEM, UNCEMENTED, L= 210 MM, Ø 20 MM, T
• 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: 25481901
• Report Number: 3004371426-2026-00047
• Device Sequence Number: 10315040
• Product Code: JDI
• UDI-Device Identifier: 04026575210732
• UDI-Public: 04026575210732
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 172-921/20
• Device Catalogue Number: 172-921/20
• Device Lot Number: 2242141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• 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: 68 YR
• Patient Sex: Unknown