MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MP MONOBLOCK; TRIAL NECK

Model Number	136-101/46
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noticed that trial stems of the mp monoblock hip prosthesis stem could only be removed with increased force after being impacted with even hammer blows.Due to the different diameters between a trial neck segment and a trial stem, a protrusion occurs on the trial stem in the transition area.When removing the trial stem from the femoral canal, this protrusion could lead to increased friction in the femoral medullary canal, so that increased force is required.The difference depends on the diameter of the selected combination of trial neck segment and trial stem.Due to the increased effort associated with the removal of the trial stem, the time of surgery may be extended and, under unfavorable circumstances, the procedure may have to be modified.As a corrective measure, all trial stems are recalled by (b)(6) 2023.Furthermore a capa was initiated to optimize the instrument.
Event or Problem Description
During the surgery, the surgeon experienced extreme difficulty in removing the trial stem, so much so that the surgeon was concerned that an osteotomy would be needed.The trial was eventually removed.This added approximately 15 minutes to the surgery.

• Brand Name: MP MONOBLOCK
• Common Device Name: TRIAL NECK
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17496625
• Report Number: 3004371426-2023-00074
• Device Sequence Number: 11361395
• Product Code: HWT
• UDI-Device Identifier: 04026575181957
• UDI-Public: 04026575181957
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 136-101/46
• Device Catalogue Number: 136-101/46
• Device Lot Number: B834128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RCL230466/RES92758
• Patient Sequence Number: 1
• Patient Sex: Unknown