MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG CONNECTION COMPONENT ROTATIONAL VERSION, SMALL

Model Number 16-2840/02

Device Problems Fracture (1260); Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 07/06/2017

Event Type  Injury  

Event Description

The patient came to clinic with excessive hyperextension.Surgery was scheduled.When the implant was exposed it was noticed that pieces of polyethylene from the medial condyle bushing were fractured and free.The hinge connecting component was only partially engaged during revision surgery.The alignment (spring) hole in the medial retractable peg portion of the connecting component (the medial axis half) that designates its location when compared to the laser mark arrow on the connecting component was noticeably lateral to the arrow, suggesting that the medial peg was not fully engaged in situ.The lateral peg alignment hole was aligned with the lateral arrow on the connecting component, suggesting that it was at the time of explanting, engaged.The central connecting component screw that locks the medial and lateral pegs into a fully engaged position was notable proud, sitting 3-4 threads above its desired flush position.Whether the screw was engaged initially in the first procedure and loosened vs.Not being engaged at all was indeterminable.The surgeon removed the existing connection component and both polyethylene condyle bushings and replaced with new ones.Surgeon confirmed the set screw was slightly recessed and tight after part replacement.Range of motion was as it should be.Surgeon commented there was no noticeable metal debris.Note: this is not a new event.The manufacturer notified fda under mdr # 3004371426-2017-00002.

• Brand Name: CONNECTION COMPONENT ROTATIONAL VERSION, SMALL
• 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: 8410453
• MDR Text Key: 138508705
• Report Number: 3006721341-2019-00007
• 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: 10/10/2017,07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2017
• Distributor Facility Aware Date: 07/07/2017
• Date Report to Manufacturer: 07/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR