MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG CONNECTION COMPONENT ROTATIONAL VERSION; ROTATING HINGED TOTAL KNEE PROSTHESIS

Catalog Number 16-2840/02

Device Problems Degraded (1153); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 12/13/2021

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to dislocation.

Event Description

It was reported that a revision surgery was performed due to dislocation.

Event Description

It was reported that a revision surgery was performed due to dislocation.

• Brand Name: CONNECTION COMPONENT ROTATIONAL VERSION
• Type of Device: ROTATING HINGED TOTAL KNEE PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: sagar shetty ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 13059403
• MDR Text Key: 285357056
• Report Number: 3004371426-2021-00037
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 16-2840/02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• 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: 18 YR
• Patient Sex: Female
• Patient Weight: 59 KG