MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM; KNEE TIBIAL INSERT FIXED

Catalog Number	02.12.0610FL
Health Effect - Clinical Code	Limited Mobility Of The Implanted Joint (2671)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on the 13 june 2019: lot 184892: (b)(4) items manufactured and released on 06-september-2018.Expiration date: 2023-08-26.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.Another implant was involved in the complaint: gmk-sphere 02.12.0006l femoral component sphere cemented size 6 l lot 186108 (k121416): (b)(4) items manufactured and released on 08-nov-2018.Expiration date: 2023-10-17.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
About 2 month after primary the surgeon revised the patient knee because painful and not able to achieve full extension.The surgeon revised successfully the 10mm insert with a 12mm insert and the femoral component.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM
• Common Device Name: KNEE TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8762588
• Report Number: 3005180920-2019-00534
• Device Sequence Number: 1679744
• Product Code: JWH
• UDI-Device Identifier: 07630030826931
• UDI-Public: 07630030826931
• 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: 2019
• 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): 07/04/2019

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: 08/26/2023
• Device Catalogue Number: 02.12.0610FL
• Device Lot Number: 184892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 07/04/2019
• 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