MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R; KNEE TIBIAL TRAY

Model Number	02.07.1203R
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A right tka revision occured on (b)(6) 2022 due to an error made by the user at the primary surgery done on (b)(6) 2022.After the primary tka done on the patient, the po x-rays revealed a poor positioning of the knee implants by the surgeon.The error was due to the fact that the patient had a valgization osteotomy at her right knee 20 years ago, which caused a change in the patient's right knee anatomy.
Additional Manufacturer Narrative
Batch review performed on 02 august 2022 lot 2115998: lot 2115998: 97 items manufactured and released on 13-apr-2022.Expiration date: 2027-03-29.No anomalies found related to the problem.To date, 64 items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed on 28-jul-2022: few days after primary cemented tka on a patient who had a previous valgization osteotomy of the tibia, the tibial component needs to be replaced for repositioning.Probably, the calcification at the site of the valgization osteotomy created a higher-resistance spot that pushed the preparation instruments and did not allow proper orientation of the tibial component, and this was not immediately perceivable by the surgeon.This adverse event was not caused by defective devices.Additional implanted components: batch review performed on 02 august 2022 gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot.2110192: lot 2110192: 25 items manufactured and released on 05-jan-2022.Expiration date: 2026-12-15.No anomalies found related to the problem.To date, 20 items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 02 august 2022 gmk-sphere 02.12.0313fr tibial insert fixed sphere flex size 3/13 mm r (k140826) lot.1908225: lot 1908225: 30 items manufactured and released on 15-ott-2019.Expiration date: 2024-09-30.No anomalies found related to the problem.To date, 14 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R
• Common Device Name: KNEE TIBIAL TRAY
• 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: 15146773
• Report Number: 3005180920-2022-00592
• Device Sequence Number: 14898424
• Product Code: JWH
• UDI-Device Identifier: 07630030819896
• UDI-Public: 07630030819896
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090988
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2022

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 Model Number: 02.07.1203R
• Device Catalogue Number: 02.07.1203R
• Device Lot Number: 2115998
• 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: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2022
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White