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 Degraded (1153)

Patient Problem Failure of Implant (1924)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time period, when the product was delivered to the customer.The cause of premature wear of the tibial pe plain bearing with delamination at the left knee joint cannot be determined with the data available to us.Without knowing the patient-specific and intraoperative necessities, it was possible to the joint more than normal.Ultimately, the final decision in favour of an implant from the surgeon, based on his individual analysis and experience for each patient.The examination of the complaint sample did not reveal any evidence of a material or manufacturing defects 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 satisfied after sled prosthesis implantation.On (b)(6) 2015 an arthroscopy of the knee joint was performed due to an external meniscus lesion.The rough delamination of the pe inlay of the medial tibial sled prosthesis, which led to the surgical revision and sled explantation on (b)(6) 2015, was revealed.

• 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: 8296669
• MDR Text Key: 134724496
• Report Number: 3004371426-2019-00028
• 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: 12/16/2015

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: 01/18/2016
• Date Manufacturer Received: 01/18/2016
• 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: 59 YR
• Patient Weight: 70