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

Model Number 16-2840/05

Device Problem Connection Problem (2900)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/04/2020

Event Type  Injury  

Event Description

On 2020-12-08, linkbio became aware of a failed connection component that was originally implanted on (b)(6) 2016 (part # 16-2840/05, sn # (b)(4)).A new connection component (part # 16-2840/05, sn # (b)(4)) was implanted during the revision surgery on (b)(6) 2020.

• Brand Name: CONNECTION COMPONENT, ROTATIONAL VERSION, MEDIUM
• Type of Device: ROTATING HINGED TOTAL KNEE PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 11008828
• MDR Text Key: 221497827
• Report Number: 3006721341-2020-00003
• 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: 12/14/2020,12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 16-2840/05
• Device Catalogue Number: 16-2840/05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2020
• Distributor Facility Aware Date: 12/08/2020
• Device Age: 4 YR
• Date Report to Manufacturer: 12/11/2020
• 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: 67 YR