MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R; FEMORAL COMPONENT CEMENTED

Model Number	02.12.0003R
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 months from tkr the surgeon performed a revision for a ligament rupture (collateral ligament).The surgery was completed successfully revising the femoral and tibial components.
Additional Manufacturer Narrative
Batch review performed on 07 february 2022: lot 2012001: (b)(4) items manufactured and released on 22-dec-2020.Expiration date: 2025-12-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs manager: tka revision due to instability.A ligament rupture has occured.The reasons of this rupture is unknown, it could be due to a trauma or a degenerative process.From the images provided a good osteointegration of the explanted implants is visible.Preliminary investigation performed by r&d manager: revision surgery of a gmk sphere after 8 months from primary surgery due to ligament rupture.Based on the picture of the explanted components, we cannot identify any anomalies that could have led to the eve.From preliminary investigation, the root cause for ligament rupture remains unknown; there is no evidence that it is related to a faulty device.Additional implant involved: gmk-sphere 02.12.0311fr tibial insert fixed sphere flex size 3/11 mm r (k140826) lot.2005738 batch review performed on 07 february 2022: lot 2005738: (b)(4) items manufactured and released on 23-july-2020.Expiration date: 2025-07-09.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: ball heads: gmk-sphere 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot.2009475 batch review performed on 07 february 2022: lot 2009475: (b)(4) items manufactured and released on 29-mar-2021.Expiration date: 2025-12-02.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 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R
• 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: 13652428
• Report Number: 3005180920-2022-00144
• Device Sequence Number: 14701507
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 03/02/2022

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: 12/13/2025
• Device Model Number: 02.12.0003R
• Device Catalogue Number: 02.12.0003R
• Device Lot Number: 2012001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2020
• 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 Age: 68 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White