MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR STD CEMENTED SIZE 3; KNEE CEMENTED FEMUR

Model Number	02.07.2003R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 november 2022.Lot 122092: (b)(4) items manufactured and released on 2-aug-2012.Expiration date: 2017-jun-30.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: 10 years after primary tka the metal components, and presumably mostly the tibia, get loose and need replacement.Aseptic loosening is a possible adverse event following tka, described in literature.Its incidence increases with time.There is no reason to suspect a faulty device at the origin of this problem.Additional implant involved: batch review performed on 22 november 2022 on gmk-primary 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot.121650.Lot 121650: (b)(4) items manufactured and released on 7-sep-2012.Expiration date: 2017-jun-30.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.
Event or Problem Description
About 10 years after the primary surgery, all components have been revised due to tibial and femoral components mobilization.The patient previously underwent revision surgery where the insert was revised and the patella bone was resurfaced.

• Brand Name: GMK-PRIMARY FEMUR STD CEMENTED SIZE 3
• Common Device Name: KNEE CEMENTED FEMUR
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15996267
• Report Number: 3005180920-2022-00926
• Device Sequence Number: 6151142
• Product Code: JWH
• UDI-Device Identifier: 07630030820205
• UDI-Public: 07630030820205
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2022

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: 06/30/2017
• Device Model Number: 02.07.2003R
• Device Catalogue Number: 02.07.2003R
• Device Lot Number: 122092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2012
• 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: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White