MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS SIZE 3NARROW / RIGHT; KNEE CEMENTED FEMORAL COMPONENT

Model Number	02.07.2213R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 may 2021: lot 174856: (b)(4) items manufactured and released on 17-oct-2017.Expiration date: 2022-10-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-primary 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot.170440.Batch review performed on 07 may 2021: lot 170440: (b)(4) items manufactured and released on 17-jun-2017.Expiration date: 2022-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: three years after primary cemented tka the patient is still painful and requires revision.Both metal components can be easily withdrawn, there is no cement adhesion on either of them, which suggests a cementation problem occurred during primary.This may be due to several different factors, such as storage temperature of the cement pasckage, temperature of the components at the time of cementation, timing of the cement application.There is no reason to suspect a faulty device.Preliminary investigation performed by r&d project manager: revision surgery of a gmk primary ps implant after 3 years from primary due to pain.In the revision procedure, both the tibial baseplate and the femoral component have been found loosened.From the pictures of the explanted components, no residual cement can be seen still adhering the implants.This suggests that a cementation problem occurred during primary, most likely caused by the cement itself or the cementation process.There is no evidence that the event is related to a faulty device.
Event or Problem Description
Revision surgery 3 years and 4 months after primary surgery.Femoral and tibial components were loose.All components revised successfully.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED PS SIZE 3NARROW / RIGHT
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11892520
• Report Number: 3005180920-2021-00429
• Device Sequence Number: 3685382
• Product Code: JWH
• UDI-Device Identifier: 07630030820977
• UDI-Public: 07630030820977
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 05/27/2021

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: 10/04/2022
• Device Model Number: 02.07.2213R
• Device Catalogue Number: 02.07.2213R
• Device Lot Number: 174856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 53