MAUDE Adverse Event Report: AMPLITUDE ANATOMIC; ANATOMIC® FIXED BEARING INSERT SIZE 3 THICKNESS 10

Model Number 1-0204730

Device Problem Misassembly by Users (3133)

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

Event Date 05/12/2021

Event Type  malfunction  

Event Description

During the surgery on (b)(6) 2021, the anatomic® tibial base plate and the anatomic® fixed bearing insert couldn't be impacted inside the tibial baseplate.Associated device: tibial base plate for fixed bearing insert cemented (reference: 1-0204903 and batch number: 308205).The surgeon removed the baseplate and implanted another tibial baseplate and insert.Extended operative time of 40 minutes without patient consequence.

Manufacturer Narrative

The review of manufacturing data shows that: - the raw material of the anatomic® insert complies with the iso 5834-2 standard.- the raw material of the anatomic® tibial base plate complies with the iso 5832-4 standard - 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 review of the internal vigilance database reveals that no other incident was reported related to the same batch number of the tibial base plate and insert.The review of the internal vigilance database since 2014 reveals that the incident rate related to per-op assembly of anatomic tibial base plate / insert is 0.007%.The visual analysis of the returned devices showed: - on the posterior part of the insert: presence of a mark on the posterior side which shows that the dovetail were not properly engaged before the impaction.- on the anterior part of the insert: deformations of the clipping beads made during the impaction and the extraction of the part.The hypothesis is that the insert was not properly pre-positioned on the tibial base plate (off-center and with on angle).There was therefore a conflict with the flange of the base plate which prevent the clipping.In conclusion and according to the elements in our possession, the exact origin of the incident cannot be established.

• Brand Name: ANATOMIC
• Type of Device: ANATOMIC® FIXED BEARING INSERT SIZE 3 THICKNESS 10
• Manufacturer (Section D): AMPLITUDE; 11 cours jaques offenbach; valence, 26000 ; FR 26000
• MDR Report Key: 12073741
• MDR Text Key: 280570338
• Report Number: 3009590742-2021-00003
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1-0204730
• Device Catalogue Number: 1-0204730
• Device Lot Number: 308807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Date Manufacturer Received: 05/31/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other