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

Model Number 15-2030/09

Device Problem Degraded (1153)

Patient Problem Failure of Implant (1924)

Event Date 10/22/2015

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 visual examination confirms the wear of the pe component.At the implants do not show any abnormalities.However, we know that with third body action, e.G.By cement residues, such wear patterns as those found in the present case.The degree of third body wear can be as follows by the weight as well as by the functional load activity of the patient can be intensified.Unfortunately, with the data available to us, the cause of the damage cannot be determined.The examination of the complaint sample did not reveal any indications 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: on (b)(6) 2009 this sled prosthesis made by them was used for my right knee.On (b)(6) 2015, i.E.After about 6 ½ years, the prosthesis had to be removed again and replaced by a new tep, because about 7-8 weeks before i had such strong pain and swelling in my knee that i could hardly walk at all.When removing the old prosthesis, the following picture emerged: a totally worn pe body with strongly yellowed edges.Please, tell me how this rapid wear can be explained.And i'll let you have it.The following engraved data serve to identify the product (uhmwpe part): ceq123, (b)(4), link: 15-2030/09, (b)(6).

• 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: 8296670
• MDR Text Key: 134723172
• Report Number: 3004371426-2019-00032
• 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: 01/06/2016

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: 15-2030/09
• Device Catalogue Number: 15-2030/09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Date Manufacturer Received: 08/05/2016
• 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: 77 YR
• Patient Weight: 92