MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG PUSH-THROUGH STEM FOR TOTAL FEMUR REPLACEMENT CEMENTED - MEGASYSTEM-C; DIAPHYSIS PROSTHESIS

Model Number 15-8523/75

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of (b)(4) at the time period, when the item was produced.The device was returned for investigation.The reported event is confirmed through investigation.There is no indication to suggest a material or manufacturing defect.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

It was reported that the sterile packaging is damaged.

• Brand Name: PUSH-THROUGH STEM FOR TOTAL FEMUR REPLACEMENT CEMENTED - MEGASYSTEM-C
• Type of Device: DIAPHYSIS PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: rebekka winterhoff ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8296391
• MDR Text Key: 134745505
• Report Number: 3004371426-2019-00067
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151008
• 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: 06/13/2017

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 15-8523/75
• Device Catalogue Number: 15-8523/75
• Device Lot Number: 1605154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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