MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MP RECONSTRUCTION PROSTHESIS

Model Number	172-921/14
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Notified by a representative who was in a procedure for an extraction of a distal stem fracture.The stem was implanted in 2014.The revision was not a linkbio product.

• Brand Name: MP RECONSTRUCTION PROSTHESIS
• Common Device Name: MP RECONSTRUCTION PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 24728219
• Report Number: 3006721341-2026-00006
• Device Sequence Number: 10265634
• Product Code: LZO
• UDI-Device Identifier: 04026575210701
• UDI-Public: 04026575210701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026
• Report Date (Section F): 03/05/2026

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?: Yes
• Device Model Number: 172-921/14
• Device Catalogue Number: 172-921/14
• Device Lot Number: 1325092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male