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

Model Number 15-8022/11

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

All product features corresponded with the valid specifications of the (b)(4) at the time, when the item was produced.The femoral component and the polyethylene plateau were available for the visual inspection.The tibia component was not explanted.The polyethylene of the buffer and bushing is damaged.The sliding surface of the polyethylene plateau shows scratches.A damage pattern as in the present case is known from cases of damage after functional overload of the components.Based on the x-ray images, a bushing failure can be confirmed.The bone defects which are clearly visible on the ct/x-ray and insufficient soft tissue tension might have contributed to the bushing failure.The investigation of the complaint sample showed no deviations and gave no indication which led to a material or manufacturing fault.Without further information like surgery report and patient data a detailed investigation is not possible.According to the quality documentation review and the investigation results a product failure is not assumed.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 (b)(4).

Event Description

Patient had small right erk implanted in (b)(6) 2015.Patient returned to the surgeon in (b)(6) 2017 with what the surgeon suspects to be a bushing failure.Patient has been referred to another surgeon for revision.

• 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: 8296687
• MDR Text Key: 134726205
• Report Number: 3004371426-2019-00082
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/17/2017

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 Expiration Date: 05/01/2019
• Device Model Number: 15-8022/11
• Device Catalogue Number: 15-8022/11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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: 64 YR