MAUDE Adverse Event Report: AESCULAP AG COREHIP EXTENDED STD C'LESS 12/14 SZ.2; HIP ENDOPROSTHETICS

Model Number NK1102T

Device Problem Osseointegration Problem (3003)

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

Event Date 04/05/2024

Event Type  malfunction  

Event Description

It was reported that there was an issue with nk1102t - corehip extended std c'less 12/14 sz.2.According to the complaint description, during implantation a bone fracture occurred.The procedure was finished without any additional treatment.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 - reportable malfunction (not later than 30 days).The assessment for the reportability of this malfunction was based on review of the applicable risk analysis.Additional information was not provided nor available.The malfunction is filed under aesculap ag reference no.(b)(4).

Manufacturer Narrative

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

• Brand Name: COREHIP EXTENDED STD C'LESS 12/14 SZ.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: 19193808
• MDR Text Key: 341790375
• Report Number: 9610612-2024-00143
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NK1102T
• Device Catalogue Number: NK1102T
• Device Lot Number: 52824803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2023
• 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