MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L; FIXED TIBIAL INSERT

Model Number	02.12.0211FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 july 2020: lot 141410: (b)(4) items manufactured and released on 12-may-2014.Expiration date: 2019-03-31.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 since 2016.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2016.On (b)(6) 2016, the patient came in due to signs of an infection and the pathogen was streptococcus mitis.The surgeon performed an i & d and swapped the poly.The surgery was completed successfully.Presently, on (b)(6) 2020, the patient came in due to signs of an infection and the pathogen is unknown, the surgeon performed an i&d and revised the poly.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10331334
• Report Number: 3005180920-2020-00477
• Device Sequence Number: 936070
• Product Code: JWH
• UDI-Device Identifier: 07630030862526
• UDI-Public: 07630030862526
• 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: 2016
• 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): 07/28/2020

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: 03/31/2019
• Device Model Number: 02.12.0211FL
• Device Catalogue Number: 02.12.0211FL
• Device Lot Number: 141410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/28/2020
• 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