MAUDE Adverse Event Report: AESCULAP AG METHA ¿CAP 12/14 130°/0° SIZE 0; HIP ENDOPROSTHETICS

Model Number NC270T

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

Patient Problem Failure of Implant (1924)

Event Date 06/13/2022

Event Type  Injury  

Event Description

It was reported that there was an issue with the product nc270t - metha cap 12/14 130°/0° size 0.According to the complaint description, the patient with primary osteoarthritis underwent a primary total hip arthroplasty in (b)(6) 2021.There was a revision arthroplasty due to loosening of the femoral component in (b)(6) 2022.A revision surgery was necessary.Additional information was not provided nor available report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.There are no further similar complaints within this batch.Explanation and rationale: without the product, an exact root cause cannot be determined at this moment.Due to the statement of the customer, that the patient fell down several times, we assume, that this might be the reason for the breakage of the implant.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: METHA ¿CAP 12/14 130°/0° SIZE 0
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17357599
• MDR Text Key: 319374591
• Report Number: 9610612-2023-00181
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NC270T
• Device Catalogue Number: NC270T
• Device Lot Number: 52622885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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
• Patient Outcome(s): Required Intervention