MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS WITH POREX SURFACE CEMENTED; ROTATING HINGED TOTAL KNEE PROSTHESIS

Model Number 15-9020/12

Device Problems Crack (1135); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to luxation of the femoral component.

Event Description

It was reported that a revision surgery was performed due to luxation of the femoral component.

• Brand Name: ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS WITH POREX SURFACE CEMENTED
• 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: 8397972
• MDR Text Key: 138073675
• Report Number: 3004371426-2019-00114
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K152431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/07/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 15-9020/12
• Device Catalogue Number: 15-9020/12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 66