MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R; KNEE TIBIAL INSERT

Catalog Number	02.12.0310FR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Knee primary surgery conducted using ka technique on (b)(6) 2024.About 2 months post primary the femoral component was dislocated posteriorly.The cause might be due to ligament laxity.The patient frequently experienced knee buckling while walking and visited the hospital.During the primary surgery, the bone resection amount and the tension during the trial were satisfactory, so the surgeon is concerned that the loosening may be due to the patient's activity.The revision surgery was done on (b)(6) 2024.The 10mm insert was replaced with a 17mm insert at the revision surgery.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17 june 2024.Lot 2318786: (b)(4) items manufactured and released on 09-aug-2023.Expiration date: 2028-07-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department.Few days after primary tka, there is a posterior dislocation and the femoral component is replaced (possibly because of damages caused by scratching on the metal tibia) and a much thicker is used, which makes us suspect that insuffient tension was present in the ligaments at the time of revision.We cannot tell if this was the case immediately after primary or if it has intervened during to some accident during rehabilitation.No reason to suspect a faulty device.Additional revised implant.Batch review performed on 17 june 2024 on gmk-sphere 02.12.1003r femoral component sphere cementless size 3 r lot.2316308 lot 2316308: (b)(4) items manufactured and released on 16-jan-2024.Expiration date: 2028-12-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.The device is not marketed in us.
Additional Manufacturer Narrative
On july 17th we have received the implant involved in the event.Visual inspection performed by knee manager: revision surgery of a gmk sphere insert after 2 months from primary implantation due to femoral posterior dislocation.No anomalies can be noted on the removed device sent back to medacta for visual investigation.From visual inspection there is no evidence that the event is related to a faulty device.Dislocation was most likely related to ligament laxity of the patient, not addressed during the primary surgery or progressively occurred after primary.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R
• Common Device Name: KNEE TIBIAL INSERT
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19708272
• Report Number: 3005180920-2024-00497
• Device Sequence Number: 6836235
• Product Code: JWH
• UDI-Device Identifier: 07630030826344
• UDI-Public: 07630030826344
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 02.12.0310FR
• Device Lot Number: 2318786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian