MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1; KNEE TIBIAL TRAY FIXED CEMENTED

Catalog Number	02.07.1201R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 june 2019: lot 151679: (b)(4) items manufactured and released on 17 april 2015.Expiration date: 2020-02-29.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: early loosening of tibial component in primary cemented tka after less than 1 year in a (b)(6) year old woman.Quality of images received does not allow a proper clinical evaluation.We cannot determine if the loosening was primarily between the metal component and cement or between cement and bone.The reason of this event cannot be determined.
Event or Problem Description
Revision surgery performed after 11 months from the primary surgery due to tibial loosening.Tibial tray and inlay have been removed.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1
• Common Device Name: KNEE TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8710810
• Report Number: 3005180920-2019-00474
• Device Sequence Number: 16810156
• Product Code: JWH
• UDI-Device Identifier: 07630030819858
• UDI-Public: 07630030819858
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• 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): 06/19/2019

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: 02/29/2020
• Device Catalogue Number: 02.07.1201R
• Device Lot Number: 151679
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/19/2019
• 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
• Patient Age: 64 YR