MAUDE Adverse Event Report: AMPLITUDE ANATOMIC; ANATOMIC® TIBIAL BASE PLATE FOR FIXED BEARING INSERT, CEMENTED

Model Number NOT COMMUNICATED

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/26/2022

Event Type  Injury  

Event Description

Loosening of the anatomic® tibial base plate for fixed bearing insert cemented size 4, 58 months after the implantation.The incident was detected during the patient clinical monitoring by the surgeon on (b)(6), 2022 the implantation was performed on (b)(6), 2017.Associated devices: anatomic® fixed bearing insert size 4 thickness 12 (reference and batch number not communicated).Anatomic® posterior stabilized femoral component cemented size 5 right (reference and batch number not communicated).

Manufacturer Narrative

No review of manufacturing data could be performed as the list of devices was not communicated by the healthcare facility.The review of the internal vigilance database since 2013 reveals that the rate related to post-operative loosening of anatomic cemented tibial component is 0.004%.The analysis of the recorded patient file during the patient clinical monitoring by the surgeon doesn't reveals any elements which could explain the loosening of the tibial component.It was noted that the patient have obesity class i (bmi : 33).Without explant, reference, batch number, x-rays and operative report, no further investigation can be performed.In conclusion and according to the elements in our possession, the origin of the loosening after 4 years remain undetermined.

• Brand Name: ANATOMIC
• Type of Device: ANATOMIC® TIBIAL BASE PLATE FOR FIXED BEARING INSERT, CEMENTED
• 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: 15892978
• MDR Text Key: 304591636
• Report Number: 3009590742-2022-00009
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NOT COMMUNICATED
• Device Catalogue Number: NOT COMMUNICATED
• Device Lot Number: NOT COMMUNICATED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 100 KG