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

Model Number	02.12.0024R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 july 2020: lot 181862: (b)(4) items manufactured and released on 27-jul-2018.Expiration date: 2023-06-14.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 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416) lot.181897 batch review performed on 13 july 2020: lot 181897: (b)(4) items manufactured and released on 01-jun-2018.Expiration date: 2023-05-13.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 02.12.T3i4r tibial tray fixed cemented size t3-i4 r (k121416) lot.172762 batch review performed on 13 july 2020: lot 172762: (b)(4) items manufactured and released on 07-sept-2017.Expiration date: 2022-08-29.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 1,5 years after primary cemented tka the whole system is revised because the patient cannot get good flexion.This is due to the position of the tibia, shown on the pre-revision xray to have anterior slope.We cannot tell if this was the situation postoperatively, due to a choice of the surgeon, or the component migrated, for unknown reasons.The cause for revision is tibia position.No reason to suspect a faulty device.
Event or Problem Description
The patient came in reporting an inability to achieve full flexion due to negative slope in the tibia.The reason of slope unknown.1 year and 7 months after primary the surgeon revised all medacta implants and replaced them with another company's product.The surgery was completed successfully.

• 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: 10282359
• Report Number: 3005180920-2020-00421
• Device Sequence Number: 485096
• Product Code: JWH
• UDI-Device Identifier: 07630030862403
• UDI-Public: 07630030862403
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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: 06/14/2023
• Device Model Number: 02.12.0024R
• Device Catalogue Number: 02.12.0024R
• Device Lot Number: 181862
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/16/2020
• 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