MAUDE Adverse Event Report: AESCULAP AG METHA SHORT HIP STEM CAP SIZE 2 HIP ENDOPROSTHETICS

Model Number NC082T

Device Problem Compatibility Problem (2960)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with metha hip stem. On (b)(6) 2009 the patient was advised to receive a surgery to treat the left hip coxarthrosis. On (b)(6) 2010 the same was advised for the right hip. Following both surgeries the patient suffered from unspecified "severe and permanent consequences", due to metallosis caused by the defective prosthesis. The patient was treated by a physician and revision(s) were performed. A revision surgery was necessary. Information about the involved products has been received, related to b)(4). The adverse event/malfunction is filed under (b)(4). Associated medwatch-reports: 9610612-2020-00080 - this report. 9610612-2020-00081 ((b)(4) nc088k). 9610612-2020-00082 ((b)(4) nc082t). Same patient- involved component (b)(4) nc088k-51555649. (9610612-2019-00781).

• Brand Name: METHA SHORT HIP STEM CAP SIZE 2
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9849315
• MDR Text Key: 184318987
• Report Number: 9610612-2020-00080
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K071916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/01/2016
• Device Model Number: NC082T
• Device Catalogue Number: NC082T
• Device Lot Number: 51540632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2009
• 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: 03/18/2020 Patient Sequence Number: 1