MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R; CEMENTED FEMORAL COMPONENT

Model Number	02.12.0024R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 september 2020: lot 163347: (b)(4) items manufactured and released on 26-jul-2016.Expiration date: 2021-07-10.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.Additional implant involved: gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.166067.Batch review performed on 16 october 2020: lot 166067: (b)(4) items manufactured and released on 11-jan-2017.Expiration date: 2022-01-01.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.Clinical evaluation performed by medical affairs director: 3.5 years after primary cemented tka mobilization of both component occurs.Judging from the images received, it is conceivable that a problem with cement or cementation occurred, as no residues of cement are visible on either explanted component.Many reasons can affect cement interdigitation with the metal components, such as temperatures (of the or and/or the storage room), timing of application, wet surfaces et others.However, a final conclusion on the causes of this revision cannot be reached.Preliminary investigation performed by r&d project manager: revision surgery after 3 years and 6 months from primary for loosening of the femoral and the tibial component.Looking at the picture of the explanted components, no residual cement can be seen on the distal surface of the tibia 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 (such as bone quality reduction, osteolysis, trauamtic event), could had played a role during time 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.
Event or Problem Description
Tibial and femoral loosening.The reason is unknown.Revision surgery successfully performed 3 years and 6 months after primary surgery removing femoral and insert components.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10689620
• Report Number: 3005180920-2020-00711
• Device Sequence Number: 3899589
• Product Code: JWH
• UDI-Device Identifier: 07630030862403
• UDI-Public: 07630030862403
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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: 07/10/2021
• Device Model Number: 02.12.0024R
• Device Catalogue Number: 02.12.0024R
• Device Lot Number: 163347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/16/2020
• 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: 84 YR
• Patient Weight: 80