MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; CONNECTION COMPONENT, INCL. TIBIAL PLATEAU, UNCEMENTED, COCRMO, UHMWPE, ROTATING

Model Number	16-2840/07
Medical Device Problem Codes	Malposition of Device (2616); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Connection component axis did not properly deploy during surgery.By moving the leg several times (extension, flexion, rotation), the connector reached the desired position in the intracondylar region, but the axis did not deploy.The connector has been exchanged.[translated description from customer].
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.The report is delayed due to original classification of the case as non-reportable.Due to the recent fda inspection we reevaluated the complaint in comparison to similar complaints with different outcomes and therefore determined that it is reportable.We have addressed this observation in capa-23-08.

• Brand Name: ENDO-MODEL SL
• Common Device Name: CONNECTION COMPONENT, INCL. TIBIAL PLATEAU, UNCEMENTED, COCRMO, UHMWPE, ROTATING
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17641709
• Report Number: 3004371426-2023-00086
• Device Sequence Number: 7936405
• Product Code: KRO
• UDI-Device Identifier: 04026575359257
• UDI-Public: 04026575359257
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2021

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 Expiration Date: 11/30/2025
• Device Model Number: 16-2840/07
• Device Catalogue Number: 16-2840/07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 95 KG