MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ROTATIONAL KNEE JOINT PROSTHESIS ENDO-MODEL®; ROTATING HINGED TOTAL KNEE PROSTHESIS

Model Number 15-8024/11

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 09/16/2015

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.Functional overload probably led to bushing damage, which may have been favoured by the varicose position of the tibial component.The final cause of the bushing damage could not be determined.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 and e.Nieder, among others, provide assistance in this respect.Katzer provide information.These studies are indicated both in the surgical technique and in the catalogue.In this case, we recommend the use of a hinged knee, as due to bone defects an insufficient extensor inhibition by the soft tissue apparatus and here a hinge knee is a more stable solution in terms of which offers lower belt tension.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

Defect bushing after 4 years and 8 months.

• Brand Name: ROTATIONAL KNEE JOINT PROSTHESIS ENDO-MODEL®
• Type of Device: ROTATING HINGED TOTAL KNEE PROSTHESIS
• 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: 8296674
• MDR Text Key: 134724498
• Report Number: 3004371426-2019-00022
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143179
• 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: 09/17/2015

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: 15-8024/11
• Device Catalogue Number: 15-8024/11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Date Manufacturer Received: 09/23/2015
• 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: 79 YR
• Patient Weight: 93