MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ L; KNEE CEMENTED FEMUR

Model Number	02.12.0022L
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 may 2021: lot 179594: (b)(4) items manufactured and released on 16-apr-2018.Expiration date: 2023-04-05.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 devices involved: batch reviews performed on 21 may 2021: gmk-sphere 02.07.1202l tibial tray fixed cemented size 2 (k090988) lot 189124: (b)(4) items manufactured and released on 7-feb-2019.Expiration date: 2024-01-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 1 similar reported event due to implant mobilization.Gmk-sphere 02.07.0033rp patella resurfacing size 1 (k090988) lot 174634: (b)(4) items manufactured and released on 29-nov-2017.Expiration date: 2022-11-08.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
1 year and 10 months after the primary surgery the patient came in reporting pain and swelling in the knee.The surgeon determined that the patient had a metal allergy.The surgeon also observed that all of the implants were loose and the cause of the loose implants are unknown.The surgeon removed all implants and revised them with new hardware.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ L
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11946158
• Report Number: 3005180920-2021-00471
• Device Sequence Number: 16474133
• Product Code: JWH
• UDI-Device Identifier: 07630030862472
• UDI-Public: 07630030862472
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 06/07/2021

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: 04/05/2023
• Device Model Number: 02.12.0022L
• Device Catalogue Number: 02.12.0022L
• Device Lot Number: 179594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/07/2021
• 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: 64 YR