MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R; KNEE FEMORAL COMPONENT

Model Number 01.26.45.1152

Device Problems Unstable (1667); Patient-Device Incompatibility (2682)

Patient Problem Joint Disorder (2373)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 25 may 2020: lot 176556: (b)(4) items manufactured and released on 09-jan-2018.Expiration date: 2022-12-18.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.Other device involved in the event: gmk-sphere 02.07.1204r tibial tray fixed cemented # 4 r lot.182908 (k090988) batch review performed on 25 may 2020: lot 182908: (b)(4) items manufactured and released on 28-sept-2018.Expiration date: 2023-09-18.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.

Event Description

The patient complained pain and instability.It was noticed that there was no bonding between the cement and the femoral and tibial implant.The cement in place was from competitor.1 year and 1 month after primary the revision surgeon revised all the implants successfully and stated that the femur implant was oversized for the patient knee.Primary surgeon was not the revision surgeon.A hinge competitor system was implanted.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R
• Type of Device: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874, sz; SZ
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 -CHE ; SZ 6874 CHE
• MDR Report Key: 10137534
• MDR Text Key: 195018095
• Report Number: 3005180920-2020-00318
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030807893
• UDI-Public: 07630030807893
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K140826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2020

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
• Device Operator: No Information
• Device Expiration Date: 12/18/2022
• Device Model Number: 01.26.45.1152
• Device Catalogue Number: 02.12.0025R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 65