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

Model Number	02.07.0033RP
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01.July.2021: lot 2003004: (b)(4) items manufactured and released on 18-jun-2020.Expiration date: 02-06-2025.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 performed by medical affairs director: few days after primary tka the cpsaule ruptured and patella dislocated.Surgical treatment consisted of re-suturing of the capsule and confirmation of patella tracking.No implanted or ancillary device is responsible for this reoperation.
Event or Problem Description
Patella dislocation was observed 3 days after the primary and 6 days after the primary an additional surgery was performed.During the additional surgery, the surgeon confirmed the joint capsule rapture.The surgeon sutured the raptured joint capsule and confirmed patella tracking.

• 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: 12148706
• Report Number: 3005180920-2021-00584
• Device Sequence Number: 11986513
• 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
• 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): 07/12/2021

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: 06/02/2025
• Device Model Number: 02.07.0033RP
• Device Catalogue Number: 02.07.0033RP
• Device Lot Number: 2003004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/12/2021
• 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 Weight: 90