MAUDE Adverse Event Report: AESCULAP AG METHA SHORT HIP STEM CAP SIZE 1 IMPLANTS METHA

Model Number NC081T

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Disorder (2373)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

Due to a lack of components, an investigation could not take place. The failure is most probably patient related. Due to the fact that we did not receive the product for investigation, a clear conclusion can not be drawn. Based on the information, it is most likely that an osteolysis led to the stem (and cup) loosening after the mentioned in-vivo time. The following information can be found in the corresponding ifu: "insufficient quality of the bone or osseous deformities, or disorders in the implant fixation area which could impair the stability of the fixation of the joint replacement primarly or over time. " the device history records have been checked for the available lot numbers and found to be according to the specification, valid at the time of production. No further complaints registered against the same lot number (51645754) of the metal stem.

Event Description

It was reported that there was an issue with metha short hip stem. According to the complaint "descripition" it was reported that the stem became loose after 5 years and 7 months. Revision surgery: (b)(6). Revision surgery: (b)(6). A revision surgery was necessary. Additional information was not provided nor available. The adverse event is filed under aag reference (b)(4).

• Brand Name: METHA SHORT HIP STEM CAP SIZE 1
• Type of Device: IMPLANTS METHA
• 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: 9968419
• MDR Text Key: 189453313
• Report Number: 9610612-2020-00140
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/01/2020
• Device Model Number: NC081T
• Device Catalogue Number: NC081T
• Device Lot Number: 51645754
• 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: 02/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/16/2020 Patient Sequence Number: 1