MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 3; KNEE PATELLA IMPLANT

Model Number 02.07.0035RP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/20/2023

Event Type  Injury  

Event Description

At about 2 years 3 months after the primary, the patient came in complaining of knee instability.The cause of the knee instability is the retinacular tear.The surgeon upsized the poly and resurfaced the patella implant.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 27 june 2023: lot 2009205: 240 items manufactured and released on 28-oct-2020.Expiration date: 2025-10-12.No anomalies found related to the problem.To date, 237 items of the same lot have been sold without any similar reported event during the period of review.Additional device involved: batch review performed on 27 june 2023: gmk-sphere 02.12.0411fr tibial insert fixed sphere flex size 4/11 mm r (k140826) lot 2001732: 75 items manufactured and released on 24-march-2020.Expiration date: 2025-03-12.No anomalies found related to the problem.To date, 64 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 3
• Type of Device: KNEE PATELLA IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17360775
• MDR Text Key: 319484242
• Report Number: 3005180920-2023-00527
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030815768
• UDI-Public: 07630030815768
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.07.0035RP
• Device Catalogue Number: 02.07.0035RP
• Device Lot Number: 2009205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White