MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; ARTICULATING SURFACE, SYMMETRIC, SZ. 3-4, UHMWPE PS, FIXED, H= 12 MM

Model Number	880-213/12
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the surgery, after implanting the tibial component, the surgeon tried to insert the poly component which struggled to enter, and above all, did not fix with the classic snap.Thinking that the pe was faulty, he opened a second identical one, but the problem repeated itself.Not knowing what to do, nobody of us was in the operating room, a third component of a higher thickness as opened but again he had difficulty inserting the component and didn't hear the usual clacking.At this point, hoping that the insert was fixed and stable, but with some concern, the surgery was finished.[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.Note on exceeding the reporting deadline.Reporting deadline 29 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.
Additional Manufacturer Narrative
This is the final supplemental report.The complaint is closed.
Event or Problem Description
During the surgery, after implanting the tibial component, the surgeon tried to insert the poly component which struggled to enter, and above all, did not fix with the classic snap.Thinking that the pe was faulty, the surgeon opened a second identical one, but the problem repeated itself.Not knowing what to do, none of us was in the or, a third component of a higher thickness was opened but again, the surgeon had difficulty inserting the component and didn't hear the usual clacking.At this point, hoping that the insert was fixed and stable, but with some concern, the surgery was finished.[customer].

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: ARTICULATING SURFACE, SYMMETRIC, SZ. 3-4, UHMWPE PS, FIXED, H= 12 MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 18542324
• Report Number: 3004371426-2024-00002
• Device Sequence Number: 18123537
• Product Code: HRY
• UDI-Device Identifier: 04026575252961
• UDI-Public: 04026575252961
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/30/2026
• Device Model Number: 880-213/12
• Device Catalogue Number: 880-213/12
• Device Lot Number: 2015096
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown