MAUDE Adverse Event Report: AESCULAP AG TIBIA EXTENSION STEM 12X52MM CEMENTED; KNEE ENDOPROSTHESES

Model Number NX062K

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Implant Pain (4561)

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 nx062k -tibia extension stem 12x52mm cemented.According to the complaint description, the patient experienced a persistent "disabling" inflammatory reaction postoperatively.An allergy consultation was performed which showed sensitivity to several metals.The initial implantation had occurred on 07sep2021.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, additional medical intervention.Additional information was not provided nor available.Additional information regarding the patient is not available.The adverse event is filed under aesculap ag reference no.(b)(4).Associated medwatch-reports: 9610612-2024-00009 (internal aesculap ag ref.No.400639120 - nx782k ) 9610612-2024-00010 (internal aesculap ag ref.No.400639121 - nx752k) 9610612-2024-00011 (internal aesculap ag ref.No.400639124 - nx062k) involved components: nx924/ e.Motion ps pro men.Comp.F4/f4n r 14mm.- lot 52495056 (internal aesculap ag ref.No.(b)(4)) nx042/ patella 3-pegs p2.- lot 52662572 (internal aesculap ag ref.No.(b)(4)).

• Brand Name: TIBIA EXTENSION STEM 12X52MM CEMENTED
• Type of Device: KNEE ENDOPROSTHESES
• 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: 18704907
• MDR Text Key: 335372353
• Report Number: 9610612-2024-00011
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101281
• 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: Initial
• Report Date: 02/13/2024

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: NX062K
• Device Catalogue Number: NX062K
• Device Lot Number: 52665381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• 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: NX042 - LOT 52662572; NX924 - LOT 52495056
• Patient Outcome(s): Required Intervention
• Patient Sex: Female