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
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10137534
• Report Number: 3005180920-2020-00318
• Device Sequence Number: 16724210
• Product Code: JWH
• UDI-Device Identifier: 07630030807893
• UDI-Public: 07630030807893
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/10/2020
• 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 Weight: 65