MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R; KNEE FEMORAL COMPONENT CEMENTED

Model Number	02.12.0005R
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director.Knee revision surgery performed 2 years and 7 months after cemented tka in a (b)(6) year old man.No information concerning patient general health status and presence of comorbidities is available.According to the report, the patient reported pain and instability.The developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.Radiographic images provided don't allow a proper clinical evaluation and the origin of pain cannot be determined.No conclusion can be drawn on the basis of available information.Batch review performed on 15 october 2021 lot 183490: 84 items manufactured and released on 25-jul-2018.Expiration date: 2023-jul-15.No anomalies found related to the problem.To date, 80 items of the same lot have been sold without any similar reported event.Additional devices involved: gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.178634 lot 178634: 120 items manufactured and released on 27-feb-2018.Expiration date: 2023-feb-13.No anomalies found related to the problem.To date, 120 items of the same lot have been sold without any similar reported event.Gmk-sphere 02.12.0512fr tibial insert fixed sphere flex size 5/12 mm r (k121416) lot.144290 lot 144290: 49 items manufactured and released on 2-oct-2014.Expiration date: 2019-aug-31.No anomalies found related to the problem.To date, 44 items of the same lot have been sold without any similar reported event since 2017.
Event or Problem Description
At 2 years and 7 months after the primary surgery the patient had revision surgery due to pain and knee instability.All implants were revised.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: KNEE 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: 12758722
• Report Number: 3005180920-2021-00860
• Device Sequence Number: 11542984
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• 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: 2019
• 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): 11/05/2021

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: 07/15/2023
• Device Model Number: 02.12.0005R
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 183490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2018
• 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: 64 YR
• Patient Sex: Male