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

Model Number 15-2818/12

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 05/03/2017

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. A functional test of the rotational bushing assembled to a tibial test component indicated no deviation. According to investigation results and production documents 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 capa-(b)(4).

Event Description

Translation: wear of rotational bushing and plateau. Instability of prosthesis.

• Brand Name: ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS
• Type of Device: ROTATIONAL 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: annerike kleine ; barkhausenweg 10; hamburg, ; GM
• MDR Report Key: 8296633
• MDR Text Key: 134725310
• Report Number: 3004371426-2019-00063
• 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: 05/08/2017

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

• Device Model Number: 15-2818/12
• Device Catalogue Number: 15-2818/12
• Device Lot Number: 1523202 (BUSHING)
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/08/2017
• 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 Treatment Data

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