MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R

Model Number	02.12.0311FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 july 2020: lot 1909432: (b)(4) items manufactured and released on 03-dec-2019.Expiration date: 2024-11-17.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.Other device involved in the event: gmk-sphere 02.12.0311fr tibial insert fixed sphere flex size 3/13 mm r lot.187250 (k140826) batch review performed on 15 july 2020: lot 187250: (b)(4) items manufactured and released on 10-dec-2018.Expiration date: 2023-11-26.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.
Event or Problem Description
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 11 days after primary.The surgery was completed successfully.The surgeon also added antibiotic cement.The same patient was scheduled to come in on (b)(6) 2020, and the surgeon checked him to see if there was an infection (there was not) and saw that the cement damaged the poly.The surgeon did a poly-swap again.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10331242
• Report Number: 3005180920-2020-00469
• Device Sequence Number: 936069
• Product Code: JWH
• UDI-Device Identifier: 07630030862588
• UDI-Public: 07630030862588
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• 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: No Information
• Device Expiration Date: 11/17/2024
• Device Model Number: 02.12.0311FR
• Device Catalogue Number: 02.12.0311FR
• Device Lot Number: 1909432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2020
• 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