MAUDE Adverse Event Report: AESCULAP AG COREHIP VAR CEMENTLESS 12/14 SIZE 1; HIP ENDOPROSTHETICS

Model Number NK1041T

Device Problem Biocompatibility (2886)

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

Event Date 01/04/2024

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 the product nk1041t - corehip var cementless 12/14 size 1.According to the complaint description, the total hip arthroplasty (tha) was performed on (b)(6) 2023.Postoperatively, there were some fratures around the stem noted.Revision surgery was necessary and was performed on (b)(6) 2024.A non-aesculap stem was then implanted.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 - serious injury (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).

Manufacturer Narrative

Additional information: h6 - codes updated.Investigation results: as of the date of this report the complaint product was not provided for investigation.The investigation was based upon analysis of historical data review, device history records, and review of x-ray image.No abnormalities could be detected on the x-ray image.The product shows no signs of damage.The fracture cannot be recognized.Batch 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 are no similar complaints against the same lot number(s) with this error pattern.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.Conclusion/preventive measures: in the light of the little information received and due to the circumstance that the complained devices were not received it is not possible to determine a root cause for the mentioned failure.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 investigation results, a capa is not required.

• Brand Name: COREHIP VAR CEMENTLESS 12/14 SIZE 1
• 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: 18695046
• MDR Text Key: 335249443
• Report Number: 9610612-2024-00001
• 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: Followup
• Report Date: 03/27/2024

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: NK1041T
• Device Catalogue Number: NK1041T
• Device Lot Number: 52759621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2022
• 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