MAUDE Adverse Event Report: AESCULAP AG EXCIA PLASMAPORE-¿CAP 8/10 SIZE 14MM; HIP ENDOPROSTHETICS

Model Number NC414T

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/11/2024

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 nc414t - excia plasmapore- cap 8/10 size 14mm.According to the complaint description, a revision surgery was performed on (b)(6) 2024, to remove the product because it had become loose due to infection.This occurred postoperatively after approximately five (5) years.The cup and stem were removed and replaced.The surgeon noted that the patient had been exhibiting signs of infection for 5 years, and that this was not related to the implant(s).A revision was required.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.The adverse event is filed under aesculap ag reference no.(b)(4).

Manufacturer Narrative

Additional information: b5 - updated description h6 - codes updated investigation results: the complained product was not available for investigation.Results were based upon batch history review, historical data analysis and event description.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 are no similar complaints against the same lot numbers.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: on the basis of the current information a clear conclusion cannot be drawn.According to the provided information "revision surgery to remove the product because it has become loose due to infection." the root cause for the mentioned infection remains unclear.There is no indication for a material defect or manufacturing failure on the basis of the device history records.Based upon investigation results, a capa is not required.

Event Description

Update: due to central migration, the product had dug into the pelvis and the cup size was 53mm, so it was difficult to dislocate it.However, once the cup ring was removed, it was possible to dislocate it.When the inner head was removed with a bone fragment driver, the stem came out along with it.The product was washed and the wound was closed with a girdle stone.Other leading materials (not marketed in usa): nj121k/ isodur prosthesis head 8/10 26mm s - lot 52447543 (internal aesculap ag reference no.(b)(4).Nk303k/ bipolar cup id26mm od53mm self-centering - lot 52167152 (internal aesculap ag reference no.(b)(4).

• Brand Name: EXCIA PLASMAPORE-¿CAP 8/10 SIZE 14MM
• 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: 18614746
• MDR Text Key: 334214680
• Report Number: 9610612-2024-00004
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060437
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NC414T
• Device Catalogue Number: NC414T
• Device Lot Number: 52273708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2016
• 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