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

Model Number	02.12.0003R
Health Effect - Clinical Codes	Discomfort (2330); Joint Laxity (4526)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31-may-2021: lot 178712: (b)(4) items manufactured and released on 2-mar-2018.Expiration date: 2023-02-20.No anomalies found related to the problem.To date, all items of the same lot have been sold without other similar reported event.Clinical evaluation performed by medical affairs director: 3 years after primary tka, the patient suffers from mid-flexion instability, in spite of having achieved good flexion and extension stability.This may be due to a particular conformation of the collateral ligament system or by the position of the initital components, not compatible with the ligamentous envelope.A revision system is chosen and artificial stability provided.No reason to suspect a faulty device at the origin of this problem.Additional items involved in the event, batch review performed on 31-may-2021.Gmk-sphere 02.12.0310fr tibial insert fixed sphere flex #3/10 mm r lot.179687: lot 179687: (b)(4) items manufactured and released on 29-mar-2018.Expiration date: 2023-03-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.07.1203r tibial tray fixed cemented # 3 r lot.156421: lot 156421: (b)(4) items manufactured and released on 30-nov-2015.Expiration date: 2020-11-11.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2017.
Event or Problem Description
Revision surgery performed 3 years after the primary due to instability in middle-flexion, lateral and medial compartments.Stability in extension and flexion.Patient with uncomfortable feeling immediately after the primary surgery.The surgeon revised all components besides patella resurfacing.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12091834
• Report Number: 3005180920-2021-00527
• Device Sequence Number: 14434662
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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: 02/20/2023
• Device Model Number: 02.12.0003R
• Device Catalogue Number: 02.12.0003R
• Device Lot Number: 178712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 06/30/2021
• 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: 65 YR
• Patient Weight: 66