MAUDE Adverse Event Report: AESCULAP AG COREHIP STD CEMENTLESS 12/14 SIZE 2; HIP ENDOPROSTHETICS

Model Number NK1002T

Device Problem Biocompatibility (2886)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

Investigation results: aesculap ag did not receive a product for investigation.Therefore the investigation results are based on device history review.Device history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There a no similar complaints against the same lot number.Conclusion/preventive measures: on basis of the available information as well as the investigation results a clear root cause conclusion cannot be drawn.There is no indication fo a material-, manufacturing- or design- related failure.In the event that the complaint sample will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigation results, a capa is not necessary.

Event Description

It was reported that there was an issue with the product nk1002t - corehip std cementless 12/14 size 2.According to the complaint description, there was a fracture around the stem observed approx.Five (5) weeks after total hip arthroplasty surgery.The fracture probably occurred when the patient was walking up steps.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision surgery.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aesculap ag reference no.(b)(4).

• Brand Name: COREHIP STD CEMENTLESS 12/14 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18658864
• MDR Text Key: 334750666
• Report Number: 9610612-2024-00005
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172235
• 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: 02/07/2024

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: NK1002T
• Device Catalogue Number: NK1002T
• Device Lot Number: 52850483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• 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