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

Model Number	136-115/00
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) was performing a mp monoblock hip surgery on (b)(6) 2023 and was trialing with a size 15 trial stem and 195 laterial trial neck and had a difficult time removing the trial.It did eventually come out after 10 to 15 minutes of trying, using extractor and slap hammer.The doctor mentioned that this is very common with the size 15 trial.Waiting information on whether trials can be sent for investigation.Updated 20230511: images and lot codes updated.Representative who reported event responded that the instruments are not broken and are needed in the set so they will not be sent back, it was reported because of the difficulty of use, which he stated was common for the size 15 trial.[customer].
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 r-2023-05.Furthermore a capa was initiated to optimize the instrument.

• Brand Name: MP MONOBLOCK
• Common Device Name: TRIAL STEM
• 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: 17496584
• Report Number: 3004371426-2023-00075
• Device Sequence Number: 6796801
• Product Code: HWT
• UDI-Device Identifier: 04026575182091
• UDI-Public: 04026575182091
• 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): 05/05/2023

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: 136-115/00
• Device Catalogue Number: 136-115/00
• Device Lot Number: B923004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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