MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG CONNECTION COMPONENT CEMENTLESS ROTATIONAL VERSION - V02 ROTATIONAL KNEE SL

Model Number 16-2840/05

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2017

Event Type  Injury  

Event Description

Rotational connection component dislocated about 1 year after implanted.Did not appear to have screw flush.Patient outcome is fine.Explant was returned to manufacturer for investigations.

• Brand Name: CONNECTION COMPONENT CEMENTLESS ROTATIONAL VERSION - V02 ROTATIONAL KNEE SL
• Type of Device: CONNECTION COMPONENT CEMENTLESS ROTATIONAL VERSION - V02 ROTATIONAL KNEE SL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 7782564
• MDR Text Key: 117129020
• Report Number: 3006721341-2018-00003
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: 16-2840/05
• Device Catalogue Number: 16-2840/05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Distributor Facility Aware Date: 09/06/2017
• Event Location: Other
• Date Report to Manufacturer: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR