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

Device Problem Positioning Failure (1158)

Patient Problem Failure of Implant (1924)

Event Date 03/19/2024

Event Type  Injury  

Event 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].

Manufacturer Narrative

This is the final supplemental report, the complaint is closed.

Event 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
• Type of Device: 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
• MDR Text Key: 340685013
• Report Number: 3004371426-2024-00031
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04026575252282
• UDI-Public: 04026575252282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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 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
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3006721341-2024-00006
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female