MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG REPLACEMENT SET FOR ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS; ROTATING HINGED TOTAL KNEE PROSTHESIS

Catalog Number 15-0027/12

Device Problem Degraded (1153)

Patient Problem Failure of Implant (1924)

Event Date 10/10/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to wear of the polyethylene components.

Event Description

It was reported that a revision surgery was performed due to wear of the polyethylene components.

• Brand Name: REPLACEMENT SET FOR ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS
• 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: 9303998
• MDR Text Key: 185495440
• Report Number: 3004371426-2019-00132
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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: 01/31/2019
• Device Catalogue Number: 15-0027/12
• Device Lot Number: 1402135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 82