MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L

Catalog Number	02.07.1203L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 months from the primary, the patient came in reporting pain due to loose implants and the cause is unknown.The surgeon revised all components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 14 december 2023 lot 1904217: 60 items manufactured and released on 13-nov-2019.Expiration date: 2024-11-02.No anomalies found related to the problem.To date, all 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 two months after primary cemented tka, all implants are reported mobilized and exchanged.This is a very rare occurrence, particularly because no clear or plausible cause has been reported.As no information is available, no conclusion can be drawn or inferred.Additional items involved in the event, batch review performed on 14 december 2023 gmk-primary 02.12.0023l femoral component sphere cemented size 3+ l (k140826) lot.1906042 lot 1906042: 101 items manufactured and released on 24-oct-2019.Expiration date: 2024-10-13.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Gmk-primary 02.07.0034rp patella resurfacing size 2 (k090988) lot.2000629 lot 2000629: 240 items manufactured and released on 12-mar-2020.Expiration date: 2025-02-24.No anomalies found related to the problem.To date, all items of the same lot have been sold with another similar reported event during the period of review.

• Brand Name: GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L
• Common Device Name: TIBIAL TRAY FIXED 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18450738
• Report Number: 3005180920-2023-01052
• Device Sequence Number: 6931352
• Product Code: JWH
• UDI-Device Identifier: 07630030819889
• UDI-Public: 07630030819889
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2024

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 Expiration Date: 11/02/2024
• Device Catalogue Number: 02.07.1203L
• Device Lot Number: 1904217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2019
• 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 Sex: Female