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

Model Number 880-201/10

Device Problems Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 07/30/2023

Event Type  Injury  

Event Description

Complaint was notified on (b)(6) 2023 about a surgery performed on (b)(6) 2023 to replace an lsk plateau because of infection.Original surgery was performed (b)(6) 2022 by dr.(b)(6).[customer].

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.This is the final suplemental report, the complaint is closed.

Event Description

Complaint was notified on 2023-08-07 about a surgery performed on (b)(6) 2023 to replace an lsk plateau because of infection.Original surgery was performed (b)(6) 2023.[customer].

• Brand Name: LINKSYMPHOKNEE
• Type of Device: 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: 17602034
• MDR Text Key: 321716518
• Report Number: 3004371426-2023-00082
• Device Sequence Number: 1
• Product Code: HRY
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

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?: No
• Device Model Number: 880-201/10
• Device Catalogue Number: 880-201/10
• Device Lot Number: 2038116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female