MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MP RECONSTRUCTION SYSTEM; MP RECONSTRUCTION PROSTHESIS, 00, TI6AL4V MICROPOROUS, CEMENTLESS, L 210

Model Number	172-921/12
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Broken hip stem.
Additional Manufacturer Narrative
The review of the device history record could not be checked as the serial number of the complained article is not available in full.This is the final supplemental report, the complaint is closed.
Event or Problem Description
Broken hip stem.

• Brand Name: MP RECONSTRUCTION SYSTEM
• Common Device Name: MP RECONSTRUCTION PROSTHESIS, 00, TI6AL4V MICROPOROUS, CEMENTLESS, L 210
• 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: 17601409
• Report Number: 3004371426-2023-00088
• Device Sequence Number: 6162244
• Product Code: JDI
• UDI-Device Identifier: 04026575320677
• UDI-Public: 04026575320677
• 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 Explanted Year: 2023
• 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): 07/24/2023
• 2 Devices were Involved in the Event: 1 2

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: 172-921/12
• Device Catalogue Number: 172-921/12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 83 YR
• Patient Sex: Female