MAUDE Adverse Event Report: AMPLITUDE ANATOMIC; BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS

Model Number 1-0204503

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 02/11/2021

Event Type  Injury  

Event Description

Loosening of the anatomic tka cemented (anatomic® posterior stabilized femoral component cemented and anatomic® tibial baseplate for fixed bearing insert) 70 months after the implantation.The incident was detected during the patient clinical monitoring by the surgeon on (b)(6) 2021.The implantation was performed on (b)(6) 2015, revision surgery performed on (b)(6) 2021.Involved devices: anatomic® posterior stabilized femoral component cemented size 3 right (reference : (b)(4), batch number : 224987) anatomic® tibial base plate for fixed bearing insert cemented size 3 (reference : (b)(4), batch number : 220452) anatomic® fixed bearing insert size 3 thickness 10 (reference : (b)(4), batch number : 222876).

Manufacturer Narrative

The raw material certificates attests that the raw materials of the component femoral, tibial base plate complies with the iso 5832-4 standard the review of the manufacturing history records shows that the devices (component femoral and tibial base plate) have been manufactured according to our specifications and drawings.The devices have been inspected during manufacturing process and no anomaly was detected.The review of the internal vigilance database shows 6 similar incidents related to post-operative loosening of an anatomic posterior stabilized femoral component cemented.The rate is (b)(4) (based on anatomic posterior stabilized femoral component cemented global sales between 2013 and (b)(6) 2023).It was noted that all these incidents were reported by the same healthcare facility.The review of the internal vigilance database shows 10 similar incidents related to post-operative loosening of an anatomic tibial base plate for fixed bearing insert cemented.The rate is(b)(4) (based on anatomic tibial base plate for fixed bearing insert cemented global sales between 2013 and (b)(6) 2023).It was noted that 7 of the 10 incidents were reported by the same healthcare facility.It was noted that the patient was operated for tibial valgus osteotomy (tvo) knee with significant 17° varus deformity on the same time that the anatomic tka implantation, which could have had an influence.The analysis of the patient file recorded during the clinical monitoring doesn't reveal other element which could explain the postoperative loosening of the anatomic tka.Without explant, no further investigation can be performed.In conclusion and according to the elements in our possession, the origin of the post-operative loosening after 5 years of implantation cannot be determined, but we cannot exclude the influence of the patient's situation.

• Brand Name: ANATOMIC
• Type of Device: BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS
• 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: 18666126
• MDR Text Key: 334834105
• Report Number: 3009590742-2024-00004
• 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: 02/08/2024

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: 1-0204503
• Device Catalogue Number: 1-0204503
• Device Lot Number: 224987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/12/2015
• 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: Male
• Patient Weight: 68 KG