MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS SIZE 6NARROW / LEFT; KNEE CEMENTED FEMUR

Model Number	02.07.2216L
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed due to cemented tibial and femur loosening, 5 months after the primary surgery.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022: lot 145573: 6 items manufactured and released on 24-oct-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review, including 145573b released on 24-mar-2020.Expiration date: 2025-03-09.Additional device involved: batch review performed on (b)(6) 2022: gmk-primary 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot 184106: 100 items manufactured and released on 2-oct-2018.Expiration date: 2023-09-18.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Preliminary investigation performed by r&d knee manager: analysing the femoral component picture received it is not possible to establish a certain root cause of the event.It is visible a mantle of cement attached to the femoral component and to the bone as well.The items are available and will be analyised.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d knee manager: revision surgery of a cemented gmk ps implant after 5 months from primary surgery due to tibial and femoral aseptic loosening.From visual inspection of the removed components sent back for investigation, we can notice that no cement is still adhering the inner surface of the implant.Actually, from picture taken just after the revision surgery, some cement was at that time present on the femoral component; it was most likely then removed during the cleaning process.Poor interdigitation between cement and implant can be related to multiple factors, most likely not implant related (such as cementation process, temperature, time, presence of fluids on the surfaces of cement interface).Absence of cement, is not an evidence of a faulty device.Some dents and scratches are visible on the polished surface of the implant, probably caused during the procedure of implant removal.No other elements relevant for the event can be noted from visual inspection.From visual inspection, there is no evidence to suspect that the event is related to a faulty device.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED PS SIZE 6NARROW / LEFT
• Common Device Name: KNEE CEMENTED FEMUR
• 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: 14840042
• Report Number: 3005180920-2022-00500
• Device Sequence Number: 4639668
• Product Code: JWH
• UDI-Device Identifier: 07630030821028
• UDI-Public: 07630030821028
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 07/26/2022

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: 09/30/2019
• Device Model Number: 02.07.2216L
• Device Catalogue Number: 02.07.2216L
• Device Lot Number: 145573B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2022
• Supplement Date Received by Manufacturer: 07/02/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2014
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White