MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 1; PATELLAR IMPLANT

Model Number	02.07.0033RP
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28.June.2021: lot 2005699: (b)(4) items manufactured and released on 3-sep-2020.Expiration date: 2025-08-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported event.Clinical evaluation performed by medical affairs director: few weeks after primary cemented tka surgery, fracture of the unresurfaced patellar bone is observed at xray control.We do not know the origin of the fracture: it may have originated at index surgery or it could be the consequence of a traumatic event, or just induced by the extensor mechanism.Not enough information to perform a thorough analysis.No reason to suspect a faulty device.Patient match planning review performed by my solution dpt.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
Patella bone fracture occurred 2 weeks after the primary surgery.3 weeks after the primary a revision surgery was performed.An artificial ligament was used for the fixation.The surgeon alleged that the patella guide was not stable while the surgeon was reaming(primary surgery).The surgeon considered the instability was potentially the root cause of this event.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 1
• Common Device Name: PATELLAR IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12216451
• Report Number: 3005180920-2021-00595
• Device Sequence Number: 19945306
• Product Code: JWH
• UDI-Device Identifier: 07630030815737
• UDI-Public: 07630030815737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 07/23/2021

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: 08/23/2025
• Device Model Number: 02.07.0033RP
• Device Catalogue Number: 02.07.0033RP
• Device Lot Number: 2005699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/23/2021
• 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: 79 YR