MAUDE Adverse Event Report: AMPLITUDE ANATOMIC; POSTERIOR STABILIZED FEMORAL COMPONENT UNCEMENTED

Model Number NOT COMMUNICATED

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/28/2023

Event Type  Injury  

Event Description

Loosening of the anatomic® tka (posterior stabilized femoral component uncemented size 5 and anatomic® tibial base plate for fixed bearing insert uncemented size 4), 40 months after the implantation.The incident was detected during the patient clinical monitoring by the surgeon on (b)(6), 2023.The implantation was performed on (b)(6), 2020.Associated device : anatomic® posterior stabilized femoral component, uncemented, size 5 (reference and batch number not communicated).Anatomic® tibial base plate for fixed bearing insert, size 4, uncemented (reference and batch number not communicated).Anatomic® fixed bearing insert size 4, thickness 10 (reference and batch number not communicated).

Manufacturer Narrative

No review of manufacturing history records could be performed as the list of devices was not communicated by the healthcare facility.The review of the internal vigilance database shows 3 incidents related to a post-operative loosening of a anatomic posterior stabilized femoral component uncemented.The rate is (b)(4) (based on anatomic femoral component global sales between 2013 and (b)(6) 2023).The review of the internal vigilance database shows 4 incidents related to a post-operative loosening of a anatomic tibial base plate for fixed bearing insert, size 4 uncemented.The rate is (b)(4) (based on anatomic femoral component global sales between 2013 and (b)(6) 2023).The analysis of the patient file recorded during the clinical monitoring doesn't reveal any element which could explain the post-operative loosening of the anatomic tka.Without explant, reference, batch number, x-rays, no further investigation can be performed.In conclusion and according to the elements in our possession, the origin of the post-operative loosening cannot be explained.

• Brand Name: ANATOMIC
• Type of Device: POSTERIOR STABILIZED FEMORAL COMPONENT UNCEMENTED
• 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: 18517593
• MDR Text Key: 332922937
• Report Number: 3009590742-2024-00001
• 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: 01/16/2024

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: 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
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/16/2024
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 85 KG