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

Model Number	02.12.0025R
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28-jul-2022.Lot 2117638: (b)(4) items manufactured and released on 09-mar-2022.Expiration date: 2027-02-23.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 devices involved: batch reviews performed on 03 august 2022: gmk-sphere 02.12.0512fr tibial insert fixed sphere flex size 5/12 mm r (k121416) lot 184232: (b)(4)items manufactured and released on 04-sept-2018.Expiration date: 2023-08-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot 2118068: (b)(4) items manufactured and released on 25-mar-2022.Expiration date: 2027-03-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
After the primary left knee surgery occurred on (b)(6) 2022, the post-op x-rays showed that right knee implants were implanted in the patient instead of left knee implants.The surgeon revised successfully the patient on (b)(6) 2022, with the correct left side implants.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R
• Common Device Name: KNEE FEMORAL CEMENTED COMPONENT
• 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: 15154694
• Report Number: 3005180920-2022-00594
• Device Sequence Number: 20095721
• Product Code: JWH
• UDI-Device Identifier: 07630030862427
• UDI-Public: 07630030862427
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2022

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 Model Number: 02.12.0025R
• Device Catalogue Number: 02.12.0025R
• Device Lot Number: 2117638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2022
• 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: Unknown