MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO MODEL SL KNEE PROSTHESIS SYSTEM; CONNECTION COMPONENT ROTATIONAL VERSION, SMALL

Model Number 16-2840/02

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 09/03/2022

Event Type  Injury  

Event Description

Linkbio was notified 09/13/2022 of a revision surgery by field representative rf due to a failing hinge in the distal femoral component of the edo model knee system sl.The hinge and bearings were swapped in the revision surgery on (b)(6) 2022 due to the hinge failure.This is the second revision performed in this patient for this issue, with the previous revision occuring on (b)(6) 2021.The surgery was reported as successful, however the explanted devices were discarded and not returned for evaluation.

• Brand Name: ENDO MODEL SL KNEE PROSTHESIS SYSTEM
• Type of Device: CONNECTION COMPONENT ROTATIONAL VERSION, SMALL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 15510403
• MDR Text Key: 300900367
• Report Number: 3006721341-2022-00006
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2022,09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• Device Lot Number: 180816/0034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/13/2022
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention