MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM R; KNEE TIBIAL INSERT

Model Number 02.12.0510FR

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Loss of Range of Motion (2032)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 5 february 2021: lot 189057: (b)(4) items manufactured and released on 15-feb-2019.Expiration date: 2024-02-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Batch review performed on 5 february 2021: gmk-sphere 02.12.0006r femoral component sphere cemented size 6 r (k121416) lot 180371: (b)(4) items manufactured and released on 22-may-2018.Expiration date: 2023-05-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs director: one year after primary cemented tka the elderly patient cannot fully extend the knee, so revision with recutting is undertaken.It's possible that excessive tightness was present and jeopardized movement.No reason to think that the problem was due to a defective device.

Event Description

The patient couldn't completely extend the leg, therefore the surgeon decided to remove the femoral component and cut it more distally.The revision surgery took place after 1 year and 2 months after the primary surgery.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM R
• Type of Device: KNEE TIBIAL INSERT
• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 11371988
• MDR Text Key: 240036727
• Report Number: 3005180920-2021-00136
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826740
• UDI-Public: 07630030826740
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K121416
• 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: 02/24/2021

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: 02/04/2024
• Device Model Number: 02.12.0510FR
• Device Catalogue Number: 02.12.0510FR
• Device Lot Number: 189057
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2019
• 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: 73 YR