MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS UNCOATED KNEE FEMUR PROSTHESIS

Model Number 15-3816/11

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 05/21/2018

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. A damage pattern as in the present case is known from cases of damage after functional overload of the components due to obese constitution of patient and insufficient soft tissue tension. 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: wear of rotational bushing.

• Brand Name: ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS
• Type of Device: UNCOATED KNEE FEMUR 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: annerike kleine ; barkhausenweg 10; hamburg, ; GM
• MDR Report Key: 8296624
• MDR Text Key: 134722761
• Report Number: 3004371426-2019-00108
• 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

• Type of Report: Initial
• Report Date: 06/26/2018

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

Device Operator

• Device Expiration Date: 11/30/2019
• Device Model Number: 15-3816/11
• Device Catalogue Number: 15-3816/11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/01/2019 Patient Sequence Number: 1