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

Model Number 15-8024/12

Device Problem Material Deformation (2976)

Patient Problem Failure of Implant (1924)

Event Date 11/03/2015

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 described clicking is probably caused by the displacement of the pe bearings which was the reason for the noise.An investigation is not possible because the complaint sample has been sterilized before we received it for investigation.The bmi of 32.5 might have had aninfluence in the destruction of the ventral uhmwpe stop.According to the quality documentation review and the investigation results we exclude a product failure and assume this incident as a single case.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

An implanted endorotational knee started 'clicking'.

• Brand Name: ROTATIONAL KNEE JOINT PROSTHESIS ENDO-MODEL®
• Type of Device: ROTATING HINGED KNEE TOTAL 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: 8296650
• MDR Text Key: 134726274
• Report Number: 3004371426-2019-00027
• 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: 11/24/2015

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: 15-8024/12
• Device Catalogue Number: 15-8024/12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Date Manufacturer Received: 12/10/2015
• 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: 53 YR
• Patient Weight: 104