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 05/15/2023

Event Type  Injury  

Event Description

Loosening of the anatomic tibial base plate for fixed bearing insert cemented 10 months after the implantation (reference and batch number not communicated).The incident was reported via our internal clinical database on july 04th, 2023.The implantation was performed on (b)(6) 2022.Associated devices: anatomic® fixed bearing insert size 1 thickness 10 (reference and batch number not communicated).Anatomic® posterior stabilized femoral component cemented size 1 (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 facilty.The review of the internal vigilance database since 2014 show 6 similar incidents for loosening on anatomic® tibial component cemented (the rate is (b)(4).) the analysis of the patient follow-up performed by our marketing teams doesn't reveal any element which could explain the loosening of the tibial baseplate.It was noted that the patient has obesity class ii (bmi : 36.3).It was reported by the surgeon that it was a loosening of the tibial baseplate on a bone sinking.Without explant, reference and batch number, no further investigation can be performed.In conclusion and according to the elements in our possession, the origin of the loosening after 10 months remains 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: 17404561
• MDR Text Key: 319845114
• Report Number: 3009590742-2023-00008
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2023

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: 07/04/2023
• Initial Date FDA Received: 07/27/2023
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 86 KG