MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE; LINKSYMPHOKNEE SYSTEM, ARTICULATING SURFACE, SYMMETRIC, SZ. 1-2, UHMWPE CR

Model Number	880-201/11
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaints was notified on 2024/03/21 that a tibial poly revision was completed by (b)(6) on (b)(6) 2024 for a disassociated poly tibial.The insert was not fully seated and was revised.[customer].
Additional Manufacturer Narrative
This is the final supplemental report, the complaint is closed.
Event or Problem Description
Complaints was notified on (b)(6) 2024 that a tibial poly revision was completed by dr.D.V on (b)(6) 2024 for a disassociated poly tibial.The insert was not fully seated and was revised.

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: LINKSYMPHOKNEE SYSTEM, ARTICULATING SURFACE, SYMMETRIC, SZ. 1-2, UHMWPE CR
• 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: 19077915
• Report Number: 3004371426-2024-00031
• Device Sequence Number: 20439092
• Product Code: HRY
• UDI-Device Identifier: 04026575252282
• UDI-Public: 04026575252282
• 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: 2022
• Device Explanted Year: 2024
• 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): 03/20/2024

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: 05/31/2026
• Device Model Number: 880-201/11
• Device Catalogue Number: 880-201/11
• Device Lot Number: 2038120
• 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: 03/20/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3006721341-2024-00006
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female