MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO MODEL M; MOD.ROTATIONKNEE, TIBIAL COMP.,SMALL, NEUTRAL

Model Number	15-2814/02
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Notified by t.A.That on (b)(6) 2024, dr.D.Was performing a revision using the endo w hinge system and 2 lots of tibial augments were opened and each had a screw that would not disengage.Cement was then used to set the augment in place.On part 15-2814/02 lot 230619/2153, only the lateral screw could be removed.On part 15-2814/02 lot 230703/1306 , only the medial screw could be removed.It was also noted that the screws that were removed were very difficult to get out, and a 2.5 screwdriver was broken in the process.Lot 230703/1306 was cemented into place.Waiting information on return of lot 230619/2153.Correction 2024-08-21:initial pn / lot number information received was inaccurate.I have received the complaint sample and it is lot 230703/1306, so lot 230619/2153 is the part that has been implanted, which was verified by the representative.Complaint sample will be shipped for investigation.[customer].
Additional Manufacturer Narrative
This is the final supplemental report.The complaint is closed.
Event or Problem Description
Notified by (b)(6).That on (b)(6) 2024, dr.(b)(6).Was performing a revision using the endo w hinge system and 2 lots of tibial augments were opened and each had a screw that would not disengage.Cement was then used to set the augment in place.On part 15-2814/02 lot 230619/2153, only the lateral screw could be removed.On part 15-2814/02 lot 230703/1306, only the medial screw could be removed.It was also noted that the screws that were removed were very difficult to get out, and a 2.5 screwdriver was broken in the process.Lot 230703/1306 was cemented into place.Waiting information on return of lot 230619/2153.Correction 2024-08-21: initial pn / lot number information received was inaccurate.I have received the complaint sample and it is lot 230703/1306, so lot 230619/2153 is the part that has been implanted, which was verified by the representative.Complaint sample will be shipped for investigation.[customer].

• Brand Name: ENDO MODEL M
• Common Device Name: MOD.ROTATIONKNEE, TIBIAL COMP.,SMALL, NEUTRAL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 20189657
• Report Number: 3004371426-2024-00061
• Device Sequence Number: 15461862
• Product Code: KRO
• UDI-Device Identifier: 04026575316281
• UDI-Public: 04026575316281
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143179
• 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: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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
• Device Model Number: 15-2814/02
• Device Catalogue Number: 15-2814/02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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 Sex: Female