MAUDE Adverse Event Report: AESCULAP AG COREHIP STD CEMENTLESS 12/14 SIZE 7; HIP ENDOPROSTHETICS

Model Number NK1007T

Device Problem Osseointegration Problem (3003)

Patient Problem Hip Fracture (2349)

Event Date 04/04/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with nk1007t - corehip std cementless 12/14 size 7.According to the complaint description, the artificial femoral head surgery on the 5th of january was completed without any problems.One week after discharge from the hospital, the patient suffered a fall fracture that let to fractures around the stem.The doctor concluded that it was a broken bone in a fall and not an implant problem.A revision surgery was necessary.This case is related to (b)(4).Additional information was not provided nor available.The adverse event is filed under aag reference 100032859 (400597104).Involved components: nk392k - isodur prosthesis head 12/14 26mm xl - lot 52777465; nk301k - bipolar cup id26mm od51mm self-centering - lot 52629695.

Manufacturer Narrative

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

Event Description

This case is related to (b)(4).The adverse event is filed under aag reference (b)(4).Involved components: nk392 - isodur prosthesis head 12/14 26mm xl - lot 52777465.Nk301k - bipolar cup id26mm od51mm self-centering - lot 52629695.

Manufacturer Narrative

Additional information: d9 - no product return.H6 - codes updated.Investigation: no investigation method could be applied, because no product was available for investigation.The provided x-ray shows the fracture of the bone in the distal area of the shaft of the implant.The prosthesis itself is undamaged.Batch 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 specification valid at the time of production.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Explanation and rationale: at this time we assume that the mentioned bone fracture is not related to our product.It is rather to be assumed that the mentioned fall of the patient led to the bone fracture.Therefore, an evaluation regarding similar incidents with our implants is not indicated.If the product is returned in the future, an investigation will again be performed and updated.Conclusion/preventive measures: based on the investigation results, a capa is not necessary.

• Brand Name: COREHIP STD CEMENTLESS 12/14 SIZE 7
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16807491
• MDR Text Key: 313939662
• Report Number: 9610612-2023-00085
• 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: 05/26/2023

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: NK1007T
• Device Catalogue Number: NK1007T
• Device Lot Number: 52655432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2020
• 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
• Treatment: NK301K - 52629695; NK301K - LOT 52629695; NK392K - 52777465; NK392K -- LOT 52777465
• Patient Outcome(s): Required Intervention