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

Model Number 1-0204503

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

The raw material certificates attest that the raw materials of the component femoral, tibial base plate comply with the iso 5832-4 standard the raw material certificates attest that the raw materials of the insert and the patellar implant comply with the iso 5834-2 standard.The review of the manufacturing history records shows that the devices (component femoral, tibial base plate, insert and patellar implant) 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 sales data shows that the totality of the batches (component femoral, tibial base plate, insert and patellar implant) were sold without any other incident reported the review of the internal vigilance database shows 3 incidents related to post-operative pain with anatomic prothesis.(b)(4).It was noted that two incidents were reported by the same healthcare facility.The analysis of the patient file recorded during the clinical monitoring doesn't reveal any element which could explain the postoperative pain after 5 years of the implantation.It was noted in the patient file a surgical procedure without change of prosthesis on (b)(6) 2018 following a patellar problem with patellofemoral impingement and also it reported on (b)(6) 2019 a patient fall in (b)(6) with a knee haematoma.It was also noted that the revision surgery was performed with an allergy solution prosthesis by another company.Following this revision, the pain persisted, the surgeon suspected residual algodystrophy and patellar tendinopathy.Without explant, x-rays, no further investigation can be performed.In conclusion and according to the elements in our possession, the origin of the post-operative pain cannot be explained.

Event Description

Unexplained pain on anatomic® (posterior stabilized femoral component cemented size 3 right and anatomic® tibial base plate for fixed bearing insert cemented size 3), 59 months after implantation.The incident was detected during the patient clinical monitoring by the surgeon on (b)(6) 2021.The chronology is as following : the implantation of the tka on right knee was performed on (b)(6) 2016.It was reported on (b)(6) 2018 a patellar problem with patellofemoral impingement (surgical procedure without change of prosthesis).It was also reported on (b)(6) 2019 a patient fall which occurred in (b)(6) 2019 with a knee haematoma.The revision surgery was performed on (b)(6) 2021 after unexplained pains persistent associated device: anatomic® posterior stabilized femoral component cemented, size 3 right (reference: (b)(4) and batch number: 243919).Anatomic® tibial base plate for fixed bearing insert cemented size 3 (reference:(b)(4) and batch number: 236952).Anatomic® fixed bearing insert size 3 thickness 10 (reference:(b)(4) and batch number : 225679).Cemented resurfacing patellar implant - 33 mm (reference: (b)(4) and batch number: 236417).

• Brand Name: ANATOMIC
• Type of Device: ANATOMIC POSTERIOR STABILIZED FEMORAL COMPONENT 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: 18658828
• MDR Text Key: 334749942
• Report Number: 3009590742-2024-00003
• 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: 02/07/2024

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 Expiration Date: 01/01/2021
• Device Model Number: 1-0204503
• Device Catalogue Number: 1-0204503
• Device Lot Number: 243919
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2016
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 77 KG