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

Model Number 136-202/01

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2022

Event Type  malfunction  

Event Description

Problems when removing the trial stem.[customer].

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 r-2023-05.Furthermore a capa was initiated to optimize the instrument.

• Brand Name: MP MONOBLOCK
• Type of Device: TRIAL ADAPTER
• 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: 17487365
• MDR Text Key: 321526186
• Report Number: 3004371426-2023-00072
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 04026575181995
• UDI-Public: 04026575181995
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/23/2022

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
• Device Operator: Health Professional
• Device Model Number: 136-202/01
• Device Catalogue Number: 136-202/01
• Device Lot Number: C051010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Removal/Correction Number: RCL230466/RES92758
• Patient Sequence Number: 1