MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MODULAR JOINT COMPONENT UNIT CONDYLAR REPLACEMENT - MEGASYSTEM-C; ROTATING HINGED TOTAL KNEE PROSTHESIS

Model Number 15-8521/15

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.

Event Description

During a surgical procedure to implant a patellar component and to address pain and inflammation, a cap of the femoral component was found loose in the joint.

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.- attachment: [complaint report (b)(4)].

Event Description

During a surgical procedure to implant a patellar component and to address pain and inflammation, a cap of the femoral component was found loose in the joint.

• Brand Name: MODULAR JOINT COMPONENT UNIT CONDYLAR REPLACEMENT - MEGASYSTEM-C
• 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: 8521592
• MDR Text Key: 142182006
• Report Number: 3004371426-2019-00121
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 15-8521/15
• Device Catalogue Number: 15-8521/15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 04/02/2019
• Supplement Dates FDA Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention