MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0024L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L; FEMORAL COMPONENT CEMENTED

Model Number	02.12.0024L
Health Effect - Clinical Codes	Crushing Injury (1797); Unspecified Infection (1930)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and pain due to a torn patella tendon.The pathogen is unknown and the reason for the torn patella tendon is unknown.At 23 days from primary the surgeon performed a washout, removed all implants, and implanted a rod.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 04 january 2022: lot 1811313: (b)(4) items manufactured and released on 27-feb-2019.Expiration date: 2024-02-18.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 implant involved: batch review performed on 04 january 2022: gmk-sphere 02.07.1204l tibial tray fixed cemented # 4 l (k090988) lot 2000558: (b)(4) items manufactured and released on 17-mar-2020.Expiration date: 2025-03-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk-sphere 02.12.0410fl tibial insert fixed sphere flex #4/10 mm l (k121416) lot 2108898: (b)(4) items manufactured and released on 09-sept-2021.Expiration date: 2026-08-29.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 02.07.0034rp patella resurfacing # 2 (k090988) lot 2108178: (b)(4) items manufactured and released on 14-sept-2021.Expiration date: 2026-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: GMK-SPHERE 02.12.0024L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13365853
• Report Number: 3005180920-2022-00046
• Device Sequence Number: 3991703
• Product Code: JWH
• UDI-Device Identifier: 07630030862397
• UDI-Public: 07630030862397
• 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: 2021
• 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): 01/27/2022

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: 02/18/2024
• Device Model Number: 02.12.0024L
• Device Catalogue Number: 02.12.0024L
• Device Lot Number: 1811313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male