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

Model Number	02.12.0510FR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 june 2023.Lot: 2108918: (b)(4) items manufactured and released on 03-aug-2021.Expiration date: 2026-jul-18.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 clinical affairs department: a primary implant of gmk sphere (right knee) was made on (b)(6) 2023.The x ray performed on day 1 post-op shows a radiolucency that could refer to a not properly engaged polyethilene inlay (displaced posteriorly).We do not have information about the clinical status of the patient.At 2-month follow up x ray (on (b)(6) 2023), the radiolucency was clearly shifted posteriorly, suggesting the inlay was completely dislocated.The root cause could be the incorrect engagement of the inlay during the first surgery.The patient underwent a new surgery to revise the insert (on (b)(6) 2023).Additional item involved in the event, batch review performed on 22 june 2023.Gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot: 2237788 lot: 2237788: (b)(4) items manufactured and released on 20-dec-2022.Expiration date: 2027-dec-06.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.
Event or Problem Description
Revision surgery performed about 1 month and a half after the primary surgery, due to intra-prosthetic dislocation of the liner from the tibial tray.The liner was not properly engaged during the primary surgery, as shown in the xrays performed 1 day post-op.Liner revised successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #SIZE 5/10 MM R
• Common Device Name: TIBIAL INSERT FIXED
• 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: 17360882
• Report Number: 3005180920-2023-00525
• Device Sequence Number: 5205894
• Product Code: JWH
• UDI-Device Identifier: 07630030826740
• UDI-Public: 07630030826740
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2023

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 Expiration Date: 07/18/2026
• Device Model Number: 02.12.0510FR
• Device Catalogue Number: 02.12.0510FR
• Device Lot Number: 2108918
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2021
• 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: 70 YR
• Patient Sex: Male