MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R

Catalog Number	02.12.0212FR
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 february 2019: lot 150465: (b)(4) items manufactured and released on 08-sep-2015.Expiration date: 2020.06 30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Other device involved: gmk-sphere tibial tray fixed cemented size 2 r, (k090988).Lot 174554: (b)(4) items manufactured and released on 10.Nov.2017.Expiration date: 2022-10-30.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.
Event or Problem Description
The patient came in complaining of instability 10 months after primary.The surgeon revised the poly, 12 mm, with a thicker implant, 14 mm.The tibial tray was revised as well, extension stem and augmention were used in the revision surgery.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8325131
• Report Number: 3005180920-2019-00047
• Device Sequence Number: 11320086
• Product Code: JWH
• UDI-Device Identifier: 07630030826184
• UDI-Public: 07630030826184
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 02.12.0212FR
• Device Lot Number: 150465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2019
• Initial Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1