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

Catalog Number 02.08.303LMRL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

On 16 may 2017 the r&d project manager performed a preliminary investigation based on the picture of the explanted femoral component and commented as follows: as reported in the event description and confirmed by the x-ray, the femoral component was found loosened in the joint.That is most likely the reason of patient's pain.Some residual cement and bone can be found on the internal surface of the explanted component.Information about the status of the cement and the position of the implant after primary surgery are not available.A possible reason for the event was the not good observance of the post-op rehabilitation indications.Elements that can lead us think that the event is related to a faulty device can't be identified.Batch review performed on 17 may 2017.Lot 160327: (b)(4) items manufactured and released on 18 march 2016.Expiration date: 2021-03-01.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.On 24 may 2017 the medical affairs director performed a clinical evaluation and commented as follows: revision of unicompartmental knee arthroplasty 1 year after primary surgery.Radiographic image provided shows the presence of a loosened femoral component.The primary position of the implant and the status of cement cannot be determined.Component loosening is a possible literature described adverse event after primary uka.In this case, the reason of failure is unknown.On 24 may 2017 the r&d project manager performed a visual inspection of the retrieved items and commented as follows: - explanted femoral component: as reported in the event description and confirmed by the x-ray, the femoral component was found loosened in the joint.Some residual cement is present in the internal surface of the component.The degree of finishing of the internal surface is in compliance with the specifications required.No scratches or signs are present on the articular surface.- explanted tibial component: some residual cement is present on the distal surface of the tibia tray.Articular surface of the insert present dents and scratches most likely caused articulating with the loosened femoral component.Conclusion: femoral component was found loosened in the joint.That was most likely the reason of patient's pain.Information about the status of the cement and the position of the implant after primary surgery are not available.A possible reason for the event was the not good observance of the post-op rehabilitation indications.There is no reason to suspect that the event is related to a faulty device.

Event Description

Since primary surgery, the patient reported pain.The surgeon said the patient did not understand spanish quite well so he was not sure the patient had followed his recommendations.The patient finally went to emergency dep of the hospital in (b)(6) 2017, with the complete decementation of the femoral component being free in the joint space, so he had to be operated again.The surgeon said the patient did not respect the post-op rehabilitation indications.On (b)(6) 2017 the patient was revised and a primary total knee prosthesis was implanted.Explants are available for further investigation.

• 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, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6587016
• MDR Text Key: 75824594
• Report Number: 3005180920-2017-00266
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K161741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2017

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: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 02.08.303LMRL
• Device Lot Number: 160327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2016
• 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: 58 YR
• Patient Weight: 85