MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ R; FEMORAL CEMENTED COMPONENT

Model Number	02.12.0023R
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 august 2021: lot 1901886: (b)(4) items manufactured and released on 17-june-2019.Expiration date: 2024-june-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation: one year after secondary tka (the insert was changed to a thicker one, implanted one year before) the prosthesis is revised to change the position (rotation) and to allow patellar tendon reconstruction.There is no reason to suspect a faulty device at the origin of this reoperation.
Event or Problem Description
1 year and 8 months after the primary surgery, the patient had a second prosthesis revision together with patellar tendon reconstruction.The surgeon thought that the femoral component was slightly inside rotated and the patient had pain.Hinge prosthesis implanted.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ R
• Common Device Name: FEMORAL CEMENTED COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12467309
• Report Number: 3005180920-2021-00738
• Device Sequence Number: 4815282
• Product Code: JWH
• UDI-Device Identifier: 07630030862380
• UDI-Public: 07630030862380
• 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: 2021
• 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): 09/14/2021

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: 06/04/2024
• Device Model Number: 02.12.0023R
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 1901886
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/14/2021
• 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: 58 YR
• Patient Weight: 84