MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL TIBIAL COMPONENT CEMENTABLE; UNCOATED UNICONDYLAR KNEE TIBIA PROSTHESIS, METALLIC

Model Number 15-2030/01

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

The visual examination confirms the heavy wear of the pe component.Since the pe of the connection component has a lower strength than the metal parts, it deformed and cracked at the described points due to the excessive forces in the joint.With the data available to us, it is unfortunately not possible to determine the cause of the damage.The examination of the complaint sample did not reveal any indications of a material or manufacturing defect causing the damage.The report is delayed due to inconsistencies with regard to foreign event reporting to fda.After re-evaluation of the complaint we determined that it is reportable.We have addressed the inconsistency in reporting foreign events to fda through capa (b)(4).

Event Description

Translation: patient complained of pain.Revision of the link sled prosthesis was performed.Severe wear of the uhmwpe component of the link sled.

• Brand Name: ENDO-MODEL TIBIAL COMPONENT CEMENTABLE
• Type of Device: UNCOATED UNICONDYLAR KNEE TIBIA PROSTHESIS, METALLIC
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer (Section G): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: omid rahmatian ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8296654
• MDR Text Key: 134723988
• Report Number: 3004371426-2019-00034
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K954186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15-2030/01
• Device Catalogue Number: 15-2030/01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 70