MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ L; FEMORAL CEMENTED COMPONENT

Catalog Number	02.12.0021L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 november 2018: lot 145238: (b)(4) items manufactured and released on 06 august 2014.Expiration date: 2019-06-30.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 other device involved: gmk-sphere tibial tray fixed cemented size 2 l reference: 02.07.1202l.Lot 154442: (b)(4) items manufactured and released on 30 november 2015.Expiration date: 2020-11-09.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: two years after primary cemented tka, both components are deemed to be loose and replaced.They appear to be correctly positioned.It is reported that the cement (from a different manufacturer) did not provide sufficient interdigitation with the device surface and therefore sufficient stability was not maintained.This normally happens due to problems intrinsic to the cement, such as temperature of the stores, temperature of the metal components at the time of insertion, or other difficulties encountered during cement preparation, application or setting.There is no reason to suspect a defect of the implanted devices.
Event or Problem Description
Revision surgery performed after 2 years from the primary due to tibial plateau loosening, all hardware were removed, the femur was well fixed.The cement was not adherent to the internal surfaces of both components removed.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ L
• Common Device Name: FEMORAL CEMENTED COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8077523
• Report Number: 3005180920-2018-00905
• Device Sequence Number: 10816744
• Product Code: JWH
• UDI-Device Identifier: 07630030862519
• UDI-Public: 07630030862519
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

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: 06/30/2019
• Device Catalogue Number: 02.12.0021L
• Device Lot Number: 145238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/16/2018
• 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: 66 YR