MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE ARTICULATING SURFACE, CR

Model Number 880-201/11

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Laxity (4526)

Event Date 03/19/2024

Event Type  Injury  

Event Description

Dr.Dv completed a tibial poly revision for a dissociated poly tibial component.The insert was not fully seated and was revised.

• Brand Name: LINKSYMPHOKNEE ARTICULATING SURFACE, CR
• Type of Device: LINKSYMPHOKNEE ARTICULATING SURFACE, CR
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 18986023
• MDR Text Key: 338698672
• Report Number: 3006721341-2024-00006
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575252282
• UDI-Public: 04026575252282
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024,03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/19/2024
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female