MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ R; KNEE FEMORAL IMPLANT

Catalog Number	02.12.0022R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 december 2019: lot 188204: (b)(4) items manufactured and released on 15-jan-2019.Expiration date: 2023-12-18.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 devices involved: batch review performed on 09 december 2019.Gmk-sphere 02.12.0210fr tibial insert fixed sphere flex size 2/10 mm r (k121416) lot 1903260: (b)(4)items manufactured and released on 25-jun-2019.Expiration date: 2024-06-09.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.Gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot 1903506: (b)(4) items manufactured and released on 19-sep-2019.Expiration date: 2024-09-09.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 medacta medical affairs manager: knee revision surgery performed 2 months after primary cemented total knee arthroplasty due to subluxation.A traumatic event was reported but it is not clear which event occurred first.Luxation may be originated by a traumatic event, progression of disease to the soft tissues or insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.
Event or Problem Description
The patient fell down on nov 24.Then the surgeon discovered that the prosthesis subluxated, it is unknown if the reason for subluxation is the fall or if the prosthesis subluxed before.Revision surgery performed successfully, 5 weeks after primary surgery, and gmk hinge has been implanted.No cement was found on the explants.The tibia has been removed without any difficulty despite the cementation was performed correctly during primary surgery.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ R
• Common Device Name: KNEE FEMORAL IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9494689
• Report Number: 3005180920-2019-01079
• Device Sequence Number: 19318303
• Product Code: JWH
• UDI-Device Identifier: 07630030862366
• UDI-Public: 07630030862366
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 12/19/2019

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: 12/18/2023
• Device Catalogue Number: 02.12.0022R
• Device Lot Number: 188204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/19/2019
• 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