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

Catalog Number	02.12.0004R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 october 2018.Lot 170259: (b)(4) items manufactured and released on 08 june 2017.Expiration date: 25.05.2022 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 tibial tray fixed cemented size t3-i4 r reference 02.12.T3i4r (k121416).Lot 171841: (b)(4) items manufactured and released on 12 july 2017.Expiration date: 2022-06-29.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 on october 17, 2018: one year after primary cemented tkr, a revision is performed because the surgeon decided the original implant positions to be suboptimal and potential cause for patient dissatisfaction.According to a very approximated analysis of the postoperative radiographs (approximation due to low quality of the images), the components seem to have been placed substantially as planned, except posterior tibial slope (lower than planned) and femoral flexum (higher than planned).We cannot determine the influence that these variations may have had on the final outcome nor the reasons that led the surgeon to make these intraoperative changes, but we find no reason to suspect a malfunctioning device.Investigation performed by patient match department on september 26, 2018: our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
About 1 year after primary surgery the surgeon revised the patient knee for femur and tibial tray mal positioning during primary.All hardware revised.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7973279
• Report Number: 3005180920-2018-00790
• Device Sequence Number: 16564500
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 10/17/2018

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: 05/25/2022
• Device Catalogue Number: 02.12.0004R
• Device Lot Number: 170259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/17/2018
• 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: 76 YR
• Patient Weight: 70