MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-UNI ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE 3 RM/LL

Catalog Number	02.08.303RMLL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 september 2018; lot 165523: (b)(4) items manufactured and released on 29 november 2016.Expiration date:2021-11-20; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on 14 september 2018; infection in cemented unicompartmental knee arthroplasty, 2 months after primary operation.Infection is a known possible adverse event following every surgery, including knee arthroplasty.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
Revision due to infection [staphylococcus epidermidis] 2 months after primary.The patient came in complaining of healing problem.The surgeon revised the femoral and the tibial components.
Additional Manufacturer Narrative
Visual inspection performed by r&d product manager on 15 november 2018: visual inspection of the explanted cemented anatomical femoral component and full pe tibial component: revision surgery after 2 months from primary implantation due to infection.Residual cement can be noted on both the explanted components.One scratch can seen on the articular surface of the femoral component most likely caused during the attempt to explant the implant.Infection is a known possible adverse event following every surgery, including knee arthroplasty.From visual inspection, there is no reason to suspect that the cause may be linked to the implanted devices.

• Brand Name: GMK-UNI ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE 3 RM/LL
• Common Device Name: ANATOMICAL FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7905418
• Report Number: 3005180920-2018-00729
• Device Sequence Number: 19279292
• Product Code: HSX
• UDI-Device Identifier: 07630030878954
• UDI-Public: 07630030878954
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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: 11/20/2021
• Device Catalogue Number: 02.08.303RMLL
• Device Lot Number: 165523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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: 59 YR
• Patient Weight: 90