MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 1 L; KNEE FEMUR IMPLANT

Model Number	02.07.2401L
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 january 2020: lot 167069: (b)(4) items manufactured and released on 21-dic-2016.Expiration date: 2021-12-06.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 other device involved batch review performed on 22 january 2020: gmk-revision 02.07.0212scf fixed tibial insert sc size 2/12mm (k103170) lot 189525: (b)(4) items manufactured and released on 1-mar-2019.Expiration date: 2024-02-17.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 or Problem Description
Revision surgery after 7 days from the primary due to dislocation (femoral component from the liner).The patient had a bone loss of the lateral femoral condyle and lateral ligament was compromised after previous revision surgery (removal of all implants due to an infection).

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 1 L
• Common Device Name: KNEE FEMUR IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9693709
• Report Number: 3005180920-2020-00044
• Device Sequence Number: 1742484
• Product Code: JWH
• UDI-Device Identifier: 07630030821363
• UDI-Public: 07630030821363
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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: 12/06/2021
• Device Model Number: 02.07.2401L
• Device Catalogue Number: 02.07.2401L
• Device Lot Number: 167069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/11/2020
• 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: 85 YR