MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED; KNEE CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0003R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection performed by r&d knee manager: revision surgery after 2 years from implantation due to knee pain on the lateral side.Cause for pain is unknown.During the revision procedure the surgeon noticed that the implants were loosened.From visual inspection of the returned components, no residual cement can be seen on the distal surface of the tibial tray and the internal surface of the femoral component.This is common findings on explanted components even if the cause for revision is not loosening.So, absence of cement on explanted components is not an evidence of a faulty device.Many other factors (like temperature, time) during cementation process could had played a role in reducing performances of interdigitation between implant and cement on both tibial and femoral side.No other aspects relevant for the event can be noted on explanted components.Batch review performed on 20 may 2019: lot 166910: (b)(4) items manufactured and released on 21-feb-2017.Expiration date: 2022-02-08.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.Another device was involved in the complaint.Batch review performed on 20 may 2019: gmk-sphere 02.07.1203r tibial tray fixed cemented # 3 r, lot 164894 (k090988): (b)(4) items manufactured and released on 12 october 2016.Expiration date: 2021-10-02.No anomalies found related to the problem.To date, all items of the same lot have been already sold with another similar reported event.
Event or Problem Description
The patient came in complaining of lateral knee pain after about 3 years from the primary surgery and the cause of pain is unknown.The surgeon performed a lateral facetectomy.During the procedure, the surgeon observed that the cement was no longer adhered to the femoral component and tibial tray and the components were loose.The surgeon revised the femoral component, tibial tray and poly with a competitor's product and the surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8640301
• Report Number: 3005180920-2019-00406
• Device Sequence Number: 16564272
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• 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: 2017
• 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): 05/24/2019

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: 02/08/2022
• Device Catalogue Number: 02.12.0003R
• Device Lot Number: 166910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/24/2019
• 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