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

Model Number	02.12.0023L
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 september 2021.Lot 2100351: (b)(4) items manufactured and released on 23-feb-2021.Expiration date: 2026-02-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional items involved in the event, batch review performed on 21 september 2021.Gmk-sphere 02.12.0310fl tibial insert fixed sphere flex size 3/10 mm l (k121416) lot.2010587 lot 2010587: (b)(4) items manufactured and released on 26-nov-2020.Expiration date: 2025-10-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot.2010234 lot 2010234: (b)(4) items manufactured and released on 25-feb-2021.Expiration date: 2026-02-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
2 months after the primary surgery the patient came in reporting pain.The surgeon observed that the tibia tendon had come off and the cause is unknown.The surgeon revised the femur, tibia, and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12589967
• Report Number: 3005180920-2021-00794
• Device Sequence Number: 19963948
• Product Code: JWH
• UDI-Device Identifier: 07630030862373
• UDI-Public: 07630030862373
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: 02/08/2026
• Device Model Number: 02.12.0023L
• Device Catalogue Number: 02.12.0023L
• Device Lot Number: 2100351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/07/2021
• 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