MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; ARTICULATING SURFACE - UHMWPE - SZ. 1-2UP CCK 20MM

Model Number	880-232/20
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
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.Note on exceeding the reporting deadline reporting deadline 30 december 2023 reporting date 19 january 2024 this initial report is delayed due to an it security-related incident from (b)(6) 2023.Due to the incident, we did not have access to our it systems and were temporarily unable to meet our obligation to report incidents on time.The process-relevant functions have been available again since 16 january 2024.Accordingly the reports will now be submitted retrospectively.
Event or Problem Description
As reported by (b)(6) dr.N could not get two 20mm plateaus to snap into place.They instead used a 22mm which snapped right into place and was implanted.Customer.
Additional Manufacturer Narrative
This is the final supplemental report, the complaint is closed.
Event or Problem Description
As reported by (b)(6), dr.(b)(6) could not get two 20mm plateaus to snap into place.They instead used a 22mm which snapped right into place and was implanted.[customer].

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: ARTICULATING SURFACE - UHMWPE - SZ. 1-2UP CCK 20MM
• 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: 18542328
• Report Number: 3004371426-2024-00006
• Device Sequence Number: 12743457
• Product Code: HRY
• UDI-Device Identifier: 04026575254293
• UDI-Public: 04026575254293
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K202924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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
• Device Expiration Date: 08/31/2026
• Device Model Number: 880-232/20
• Device Catalogue Number: 880-232/20
• Device Lot Number: 2111025
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• 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: 61 YR
• Patient Sex: Female