MAUDE Adverse Event Report: AMPLITUDE ANATOMIC; ANATOMIC FIXED BEARING INSERT, SIZE 2, LEFT SIDE

Model Number 1-0204402

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 02/16/2022

Event Type  Injury  

Event Description

The patient came in consultation for chronic pain and an allergy to nickel was discovered (total knee prosthesis initially implanted in 2017).A total knee prosthesis revision has been performed on (b)(6) 2022 with implantation of an anti-allergical prosthesis.Total knee prosthesis implanted device: anatomic posterior stabilized femoral component cementless ha coated size 2 left (reference: 1-0204402, batch number : 259094).Anatomic®  fixed bearing insert size 3 thickness 10 (reference: 1-0204730, batch number : 256830).Anatomic tibial base plate for fixed bearing insert cementless ha coated size 3 (reference : 1-0204803, batch number : 246992).

Manufacturer Narrative

The review of manufacturing data shows that: the review of the manufacturing history records shows that the devices have been manufactured according to our specifications and drawings.100% of the parts have been inspected during manufacturing process and no anomaly was detected.The raw material of the anatomic® femoral component and anatomic® tibial component are complies with iso 5832-4 standard.The device was not evaluated as the review of manufacturing data does not show anomaly and that the incident is related to an allergic reaction.The review of the current instruction for use no154 related to anatomic total knee prosthesis mention the presence of chromium cobalt alloy (cocrmo) acccording to iso 5832-4.The composition of this alloy includes 1.00% of nickel (ni).The ifu also mentions the contraindication of implantation in case of allergy to the metals constituting the implant.The review of the internal vigilance database since 2014 does not show similar incident for nickel allergy.In conclusion and according to the elements in our possession, the incident is related to a allergic reaction without device problem found.

• Brand Name: ANATOMIC
• Type of Device: ANATOMIC FIXED BEARING INSERT, SIZE 2, LEFT SIDE
• Manufacturer (Section D): AMPLITUDE; 11 cours jacques offenbach; za mozart 2; 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: 13902170
• MDR Text Key: 287904999
• Report Number: 3009590742-2022-00003
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: 1-0204402
• Device Catalogue Number: 1-0204402
• Device Lot Number: 259094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2017
• 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