MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-UNI ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE 3 LM/RL

Catalog Number 02.08.303LMRL

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02 july 2018; lot 146709: (b)(4) items manufactured and released on 21 november 2014.Expiration date: 2019-10-31; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Reference 02.08.Tf3.Lmrl fixed tibial base #3 lm-rl (not marketed in us); lot 141813: (b)(4) items manufactured and released on 10 april 2014.Expiration date: 31.03.2019.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed on 06 july 2018 by meidcal affairs (b)(4).Mobilization of femoral component in cemented uka few months after primary surgery.The xrays supplied are not dated, but it seems that the femoral component was mobilized immediately after surgery.This may be due to a problem with cementation or it could have been originated by an intraoperative unforeseen occurrence; there is no reason to suspect that it was caused by a faulty device.Preliminary investigation based on the pictures of the explanted femoral and tibial component performed on 06 july 2018 ba r&d product manager: tibial and femoral loosening after 7 months from primary implantation of unicondylar knee implant.Some residual cement can be seen on the distal surface of the explanted tibial component.At the contrary, any residual cement can't be noted on the explanted femoral component.This is something usual to be seen on explanted components even if the cause of revision is not instability, loosening or mobilization.Therefore, lack of cement on the distal surface is not an evidence of lack of adhesion between the cement and the implant.Loosening could be linked to failure of cement or of the cementation process that is associated to several factors not implant related.Some portions of the tibial insert turn their color into yellow.This is something already experienced and deeply analyzed in medacta and the conclusion is that the possible reason of the change of the color should be the absorption of lipids from the synovial fluid present in the joint of the patient.

Event Description

Revision surgery due to femoral and tibial loosening 7 months after primary.The surgeon noticed that the cement did not adhere to the femoral component but on the tibial base it was noticeable.

• Brand Name: GMK-UNI ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE 3 LM/RL
• Type of Device: ANATOMICAL FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7666245
• MDR Text Key: 113310758
• Report Number: 3005180920-2018-00485
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K161741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 02.08.303LMRL
• Device Lot Number: 146709
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2014
• 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: 67 YR
• Patient Weight: 95