MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

Catalog Number	02.12.0412FR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 december 2019.Lot 1811496: (b)(4) items manufactured and released on 09-apr-2019.Expiration date: 20.03.2024.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.Additional implant involved: gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.189152.Batch review performed on 17-dec-2019.Lot 189152: (b)(4) items manufactured and released on 08-feb-2019.Expiration date: 30/01/2024.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 had a primary knee surgery on (b)(6) 2019.On (b)(6) 2019, the patient came in due to signs of an infection.The surgeon performed a washout and poly-swap and the surgery was completed successfully.Presently, on (b)(6) 2019, the patient came in complaining of pain and it was observed that the poly had become disengaged, no screw was used.The surgeon revised the poly and the surgery was completed successfully using the screw.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9494236
• Report Number: 3005180920-2019-01080
• Device Sequence Number: 1541940
• Product Code: JWH
• UDI-Device Identifier: 07630030826580
• UDI-Public: 07630030826580
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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: 03/20/2024
• Device Catalogue Number: 02.12.0412FR
• Device Lot Number: 1811496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/19/2019
• 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