MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODELL. MODULAT ROTATION KNEE, FEMORAL COMPONENT

Model Number 15-2812/12

Device Problem Material Deformation (2976)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 03/19/2017

Event Type  Injury  

Manufacturer Narrative

All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.

Event Description

Pain in the knee joint area and a feeling of instability for 1 year.There was a pathological medial and lateral folding in the knee as a sign of damage to the inserted socket mechanism of the rotational knee endoprosthesis left knee.During the operation on (b)(6) 2018 the joint socket of the pivot joint was destroyed.The polyethylene is completely crushed and broken.There was a particle abrasion reaction of the knee joint.The upper part and the lower part of the prosthesis are fixed.There was isolated damage to the book mechanism.[translation].

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.The t-piece, the bearing shells, the tibia component and the polyethylene plateau were available for the visual examination.The bushing was not provided.The service life was approximately 2 years and 9 months.The x-rays show a non-parallel joint line, which indicates a socket damage.It is assumed that an insufficiently stable soft tissue situation caused by multiple prosthesis changes at an unknown activity level of the patient led to functional and mechanical overloading or overstretching of the coupling mechanism and thus to socket damage of the implant.The patient's bmi is 34.According to our instructions for use, obesity is a relative contraindication.The final cause of the socket damage could not be determined because the socket was not available.The examination of the received complaint samples did not reveal any indications of a material or manufacturing defect causing the damage.A damage pattern as in the present case is known from damage cases after functional overload.Ultimately, the final decision for an implant must be made by the surgeon based on his individual analysis and experience for each patient.The studies by e.Nieder [2] and e.Nieder [2], among others, provide assistance in this respect.Katzer [1] provide information.The waldemar link gmbh & co.Kg is aiming for the highest product quality and trying to keep the failure rate as low as possible by means of the customer feedback.Permanent employee trainings and market surveillance are performed.[translation].

Event Description

Pain in the knee joint area and a feeling of instability for 1 year.There was a pathological medial and lateral folding in the knee as a sign of damage to the inserted socket mechanism of the rotational knee endoprosthesis left knee.During the operation on 6.6.2018 the joint socket of the pivot joint was destroyed.The polyethylene is completely crushed and broken.There was a particle abrasion reaction of the knee joint.The upper part and the lower part of the prosthesis are fixed.There was isolated damage to the book mechanism.[translation].

• Brand Name: ENDO-MODELL. MODULAT ROTATION KNEE, FEMORAL COMPONENT
• Type of Device: ENDO-MODELL. MODULAT ROTATION KNEE, FEMORAL COMPONENT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 7881014
• MDR Text Key: 120415028
• Report Number: 3004371426-2018-00010
• 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: 06/17/2019

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: 03/31/2020
• Device Model Number: 15-2812/12
• Device Catalogue Number: 15-2812/12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/17/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 95