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

Model Number	136-202/01
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
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 r-2023-05.Furthermore a capa was initiated to optimize the instrument.
Event or Problem Description
Problems were encountered when removing the trial (195 x 16 mm with lateralized trial body): he had to add the extra impaction and it took a lot of hits to remove the trial.With the force he used, it made it near impossible to catch the trial once it did come out, and unfortunately the whole trial hit the floor.With his original trial being contaminated, we had to trial with the 195x15 and the standard neck- not exactly a great way to check for an accurate fit.This ended up impeding the case as we had to x-ray with the real implant, and had to then remove the real implant to re-ream after seeing the scans.Overall was happy with the outcome for the patient, but it could have gone smoother with better instrumentation.[customer].

• Brand Name: MP MONOBLOCK
• Common Device Name: 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: 17496585
• Report Number: 3004371426-2023-00073
• Device Sequence Number: 15152618
• Product Code: HWT
• UDI-Device Identifier: 04026575181995
• UDI-Public: 04026575181995
• 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): 10/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: 136-202/01
• Device Catalogue Number: 136-202/01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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