MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ R; KNEE CEMENTED FEMUR

Model Number	02.12.0023R
Health Effect - Clinical Code	Limited Mobility Of The Implanted Joint (2671)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 march 2020: lot 1810113: (b)(4) items manufactured and released on 07-feb-2019.Expiration date: 2024-01-23.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 05 march 2020: gmk-sphere 02.12.0210fr tibial insert fixed sphere flex size 2/10 mm r (k121416) lot 186055: (b)(4)items manufactured and released on 29-nov-2018.Expiration date: 2023-11-19.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.Gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot 171148: (b)(4) items manufactured and released on 28-june-2017.Expiration date: 2022-06-12.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 came in reporting stiffness and pain in the knee.The cause of the knee stiffness and pain is patella baja.7 months after primary surgery the surgeon revised successfully the knee swapping the femoral and tibial components.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ R
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9880470
• Report Number: 3005180920-2020-00177
• Device Sequence Number: 2794046
• Product Code: JWH
• UDI-Device Identifier: 07630030862380
• UDI-Public: 07630030862380
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2020

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: Health Professional
• Device Expiration Date: 01/23/2024
• Device Model Number: 02.12.0023R
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 1810113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/25/2020
• 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