MAUDE Adverse Event Report: AMPLITUDE ANATOMIC; ANATOMIC® FIXED BEARING INSERT SIZE 4 THICKNESS 10

Model Number 1-0204740

Device Problem Inaccurate Information (4051)

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

Event Date 05/12/2023

Event Type  malfunction  

Event Description

It was detected that the reference on the traceability labels corresponds to a score® patellar resurfacing implant cemented.33 mm instead of an anatomic® fixed bearing insert size 4 thickness 10.The error was detected after the surgery, during the consultation of the patient record by the pharmacy.There was no related patient consequences.

Manufacturer Narrative

The review of the manufacturing history records of the batch 334199 confirm the non-conformity of the labels, with the presence of the reference ".1-0200833" corresponding to an score® patellar resurfacing implant cemented ø 33 mm on the internal label / patient label instead of the reference "1-0200833." corresponding to an anatomic® fixed bearing insert size 4 thickness 10.The investigations rebeals that the origin of the incident is due to a computer malfunction during printing of the labels.This error has not been detected during inspection before release.Capa (corrective action and preventive action) has been initiated in order to implement actions to avoid the reccurence.As a precautionary measure, amplitude is performing a field safety notice, an advisory notice is sent to the involved customers.The involved batch has not been distributed in us (no product on us market).

• Brand Name: ANATOMIC
• Type of Device: ANATOMIC® FIXED BEARING INSERT SIZE 4 THICKNESS 10
• 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: 17018780
• MDR Text Key: 316102282
• Report Number: 3009590742-2023-00006
• 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
• Remedial Action: Notification
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1-0204740
• Device Catalogue Number: 1-0204740
• Device Lot Number: 334199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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