MAUDE Adverse Event Report: AESCULAP AG COREHIP STD CEMENTLESS 12/14 SIZE 6; HIP ENDOPROSTHETICS

Model Number NK1006T

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 04/28/2023

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 nk1006t - corehip std cementless 12/14 size 6.According to the complaint description, the patient fell eight days after the total hip arthroplasty surgery.He was about to stumble, so he held on, but he lost his balance and fell.After the fall a fracture around the stem was noticed.  a revision surgery was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: due to the fact that no product was provided, an investigation is not possible.Device history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products were found to be according to our specifications valid at the time of production.Conclusion and preventive measures: the provided x-rays show the fracture of the bone in the distal area of the shaft of the implant.The prosthesis is undamaged.The bone fracture is not related to our product, but to the fall of the patient.Therefore, an evaluation regarding similar incidents with our implants is not indicated.Based upon the investigation results, a capa is not necessary.

• Brand Name: COREHIP STD CEMENTLESS 12/14 SIZE 6
• 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: 16950666
• MDR Text Key: 315442509
• Report Number: 9610612-2023-00114
• 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,Followup
• Report Date: 08/24/2023

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: NK1006T
• Device Catalogue Number: NK1006T
• Device Lot Number: 52795211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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