MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MP RECONSTRUCTION SYSTEM; HIP PROSTHESIS STEM, UNCEMENTED, L= 210 MM, Ø 14 MM, TI6AL4V, POROLINK

Model Number	172-921/14
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
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.
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 lb product.Unknown event date.The extracted product was discarded."[customer]".
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 lb product.Unknown event date.The extracted product was discarded."[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.This is the final supplemental report, the complaint is closed.

• Brand Name: MP RECONSTRUCTION SYSTEM
• Common Device Name: HIP PROSTHESIS STEM, UNCEMENTED, L= 210 MM, Ø 14 MM, TI6AL4V, POROLINK
• 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: 24615507
• Report Number: 3004371426-2026-00024
• Device Sequence Number: 10137999
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K142187
• 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: Manufacturer
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2013
• 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: Male