MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL SL KNEE JOINT PROSTHESIS; CONNECTION COMPONENTROTATIONAL VERSION,MEDIUM

Model Number	16-2840/05
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The case had proceeded according to the plan delivered by custom link and implants (see usage stickers below) had been cemented in place with the hinge component still to be inserted in the tibia and engaged within the femur.As per the technique dr h.Placed the hinge component (16-2840/05 (b)(6) into the tibia and fitted the polyethylene anti-luxation component.Access was difficult due to the tightness of the extensor mechanism (too tight to evert the patella as per standard tka practice so it was retracted laterally instead).It was also not possible to have the leg flexed more than 90° during implantation either.This resulted with limited space and it was very difficult to locate the hinge component into the intra-condylar slot of the femur.During this process of trying to locate the hinge the securing sleeve was rotated out of its locked position by the patella and the locating axis and spring all came apart.Fortuitously the pieces were contained within the wound and the components able to be put back together.When the hinge was able to be located into place the locking screw could not be driven forward into position.Dr h.Backed the locking screw out and upon inspection said it was damaged and looked like it had been cross threaded.Without having a second rotating hinge component available a fixed hinge was opened to retrieve the locking screw from it (dr h.Did not wish to try and remove the engaged rotating hinge to replace with the fixed hinge).This was screwed in but was very tight and would not seat all the way.With some effort it was inserted deep enough so that it did not impinge against the femur during range of motion trials.This process of locating the hinge caused the surgery time to be lengthened by approximately 30-45min.In the short term it has not affected the patient, dr h.Reported that he was in good condition the following morning.[customer].
Additional Manufacturer Narrative
This is the final supplemental report, the complaint is closed.
Event or Problem Description
The case had proceeded according to the plan delivered by customlink and implants (see usage stickers below) had been cemented in place with the hinge component still to be inserted in the tibia and engaged within the femur.As per the technique dr h.Placed the hinge component (16-2840/05 sn (b)(6) into the tibia and fitted the polyethylene anti-luxation component.Access was difficult due to the tightness of the extensor mechanism (too tight to evert the patella as per standard tka practice so it was retracted laterally instead).It was also not possible to have the leg flexed more than 90° during implantation either.This resulted with limited space and it was very difficult to locate the hinge component into the intra-condylar slot of the femur.During this process of trying to locate the hinge the securing sleeve was rotated out of its locked position by the patella and the locating axis and spring all came apart.Fortuitously the pieces were contained within the wound and the components able to be put back together.When the hinge was able to be located into place the locking screw could not be driven forward into position.Dr (b)(6).Backed the locking screw out and upon inspection said it was damaged and looked like it had been cross threaded.Without having a second rotating hinge component available a fixed hinge was opened to retrieve the locking screw from it (dr (b)(6).Did not wish to try and remove the engaged rotating hinge to replace with the fixed hinge).This was screwed in but was very tight and would not seat all the way.With some effort it was inserted deep enough so that it did not impinge against the femur during range of motion trials.This process of locating the hinge caused the surgery time to be lengthened by approximately 30-45min.In the short term it has not affected the patient, dr h.Reported that he was in good condition the following morning.[customer].

• Brand Name: ENDO-MODEL SL KNEE JOINT PROSTHESIS
• Common Device Name: CONNECTION COMPONENTROTATIONAL VERSION,MEDIUM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 19558632
• Report Number: 3004371426-2024-00049
• Device Sequence Number: 14655644
• Product Code: KRO
• UDI-Device Identifier: 04026575359240
• UDI-Public: 04026575359240
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/23/2024

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: 16-2840/05
• Device Catalogue Number: 16-2840/05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Male