MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0006L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The primary surgery was performed on (b)(6) 2018.On (b)(6) 2019, the patient underwent revision surgery due to infection.On (b)(6) 2021, the patient was revised for the second time for aseptic tibial loosening.Presently, on (b)(6) 2022, the patient was revised for the third time because of infection.The surgeon performed a single stage revision and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 26-aug-2022: lot 189011: (b)(4) items manufactured and released on 30-jan-2019.Expiration date: 2024-01-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of the review.Additional components involved: gmk-sphere 02.09.Ta410 tibial augmentation size 4/10mm (k130299) lot 189443: (b)(4) items manufactured and released on 10-apr-2019.Expiration date: 2024-03-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot 1909672: (b)(4) items manufactured and released on 12-dec-2019.Expiration date: 2024-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of the review.Gmk-sphere 02.07.0684l revision fixed tibial tray cemented size 4 l (k123721) lot 1810579: (b)(4) items manufactured and released on 02-apr-2019.Expiration date: 2024-03-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no other similar reported case during the period of the review.Gmk-sphere 02.07.Fsc13105 extension stem - cemented ø 13 l 105 (k120790) lot 1901744: (b)(4) items manufactured and released on 17-jul-2019.Expiration date: 2024-07-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no other similar reported case during the period of the review.Lot of the femoral component is not available.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15438884
• Report Number: 3005180920-2022-00694
• Device Sequence Number: 6005131
• Product Code: JWH
• UDI-Device Identifier: 07630030825873
• UDI-Public: 07630030825873
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/15/2022

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: 01/13/2024
• Device Model Number: 02.12.0006L
• Device Catalogue Number: 02.12.0417FL
• Device Lot Number: 189011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2019
• 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 Age: 82 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian