MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG LINKSYMPHOKNEE; ARTICULATING SURFACE, SYMMETRIC, SZ. 5-6, UHMWPE PS, FIXED, H= 10 MM

Model Number	880-215/10
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The insert does not fully adhere to the tibia at the front and therefore does not lock.The item was discarded because of this malfunction and we used another new insert (ps+), which fitted at the first attempt without any problem.[customer].
Additional Manufacturer Narrative
This is the final supplemental report.The complaint is closed.
Event or Problem Description
The insert does not fully adhere to the tibia at the front and therefore does not lock.The item was discarded because of this malfunction and we used another new insert (ps+), which fitted at the first attempt without any problem.[customer].Update: the item is not discarded.

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: ARTICULATING SURFACE, SYMMETRIC, SZ. 5-6, UHMWPE PS, FIXED, H= 10 MM
• 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: 19057527
• Report Number: 3004371426-2024-00029
• Device Sequence Number: 6677585
• Product Code: HRY
• UDI-Device Identifier: 04026575253159
• UDI-Public: 04026575253159
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K202924
• 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,Followup
• Report Date (Section B): 03/13/2024

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: 880-215/10
• Device Catalogue Number: 880-215/10
• Device Lot Number: 2334113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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 Sex: Unknown