MAUDE Adverse Event Report: AMPLITUDE ANATOMIC; ANATOMIC® POSTERIOR STABILIZED FEMORAL COMPONENT CEMENTED SIZE 3, RIGHT SIDE

Model Number 1-0204503

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/03/2023

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing history records shows that the devices have been manufactured according to our specifications and drawings.No anomaly in relation to the vigilance has been detected.100% of the parts have been inspected during manufacturing process and no anomaly was detected on the final product.The instruction for use no109 revision i, applicable at the date of implantation, lists the materials used for the manufacture of the device.Some components are manufactured from cobalt chromium cobalt alloy (cocrmo) according to iso 5832-4.This alloy includes a maximum of 1.00% of nickel (ni).The raw material certificates shows that percentage of nickel (ni) in the involved components complies with iso 5832-4 standard (anatomic® femoral component include 0.11% of nickel (ni) and anatomic® tibial component include 0.17% of nickel (ni)).The ifu no109 version i describes " allergies to the materials present in the implant." as a contra-indication.The patient follow-up in our internal clinical database reports a regular monitoring of the patient by the surgeon.It is mentioned that the patient is fully satisfied of the prothesis (7 follow up since implantation, the last one was performed at 8 years and 9 months).The review of the internal vigilance database since 2014 shows 1 similar incident for nickel allergy (rate is 0.0019%).Without the extra information (explants, operative report, allergic test result), no further analysis could be performed.In conclusion and according to the elements in our possession, no root-cause can be determined.It should be noticed that the reason for revision (suspicion of allergy to nickel) is not clinically confirmed.There is no element that could jeopardize the device.

Event Description

This incident was reported via our internal clinical database the surgeon who performed the implantation of the anatomic total knee prosthesis reported that the patient had a revision surgery in another healthcare facility following a suspicion of nickel allergy without loosening of the tkp.Tkp involved devices: - anatomic® posterior stabilized femoral component cemented size 3 right (reference 1-0204503, batch 148424).- anatomic® tibial base plate for fixed bearing insert cemented size 3 (reference 1-0204903, batch number 145130).- anatomic® fixed bearing insert size 3 thickness 10 (reference 1-0204730, batch number 164745).

• Brand Name: ANATOMIC
• Type of Device: ANATOMIC® POSTERIOR STABILIZED FEMORAL COMPONENT CEMENTED SIZE 3, RIGHT SIDE
• Manufacturer (Section D): AMPLITUDE; 11 cours jacques offenbach; valence, 26000 ; FR 26000
• Manufacturer (Section G): AMPLITUDE; 11 cours jacques offenbach; valence, 26000 ; FR 26000
• Manufacturer Contact: mireille lemery ; 11 cours jacques offenbach; valence, 26000 ; FR 26000
• MDR Report Key: 17018839
• MDR Text Key: 316123518
• Report Number: 3009590742-2023-00007
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/30/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1-0204503
• Device Catalogue Number: 1-0204503
• Device Lot Number: 148424
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2013
• 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
• Patient Sex: Female
• Patient Weight: 76 KG