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

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

Event Description

The insert does not attach to the tibial prosthesis.The item was discarded because of this malfunction and we used another new insert, which fitted at the first attempt without any problem [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.

Event Description

The insert does not attach to the tibial prosthesis.The item was discarded because of this malfunction and we used another new insert, which fitted at the first attempt without any problem [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.This is the final supplemental report, the complaint is closed.

• 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: 17403281
• MDR Text Key: 320686597
• Report Number: 3004371426-2023-00052
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K202924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

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: 2233240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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 Sex: Female