MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R E-CROSS; KNEE TIBIAL INSERT

Catalog Number 02.12.E0310FR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 02/15/2024

Event Type  Injury  

Event Description

At about 6 months after the primary, the patient came in reporting pain and the cause is unknown.The surgeon revised the poly and patella resurfacing.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 27 february 2024: lot 2243360: (b)(4) manufactured and released on 26-jan-2023.Expiration date: 2028-01-09.No anomalies found related to the problem.To date, (b)(4) 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 february 2024: gmk-sphere 02.12.E001rp patella resurfacing size 1 e-cross (k202022) lot 2243920: (b)(4) manufactured and released on 12-jan-2023.Expiration date: 2027-12-15.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R E-CROSS
• Type of Device: KNEE TIBIAL INSERT
• 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: 18844188
• MDR Text Key: 336958854
• Report Number: 3005180920-2024-00128
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630971261525
• UDI-Public: 07630971261525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.12.E0310FR
• Device Lot Number: 2243360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2023
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Race: White