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

Model Number 16-2840/02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 12/13/2021

Event Type  Injury  

Event Description

Per sales rep: the pre-surgery x-rays clearly showed that the knee was dislocated.Upon making an incision it was immediately visible that bushings were damaged.Medial piston that was visible in the x-ray was not deployed.When tibial was exposed, lateral piston was missing.Sales rep noticed that the locking screw was not fully seated and was seating proud (2-3 threads) and pointed it out to surgeon.Surgeon confirmed that she did not deviate from the surgical technique when the implant was implanted.

• 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: 13022951
• MDR Text Key: 282389783
• Report Number: 3006721341-2021-00007
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2021,12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2021
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 59 KG