MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM; KNEE TIBIAL INSERT

Model Number	02.07.0412FUC
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 11 years 5 months after the primary, the patient came in reporting anterior knee pain and the cause is unknown.The surgeon upsized the poly (12 to 14 mm) and revised the patella implant.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 03 october 2022: lot 104103: (b)(4) items manufactured and released on 03-feb-2011.Expiration date: 2015-12-31.No anomalies found related to the problem.To date, (b)(4) 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 03 october 2022: gmk-primary 02.07.0034rp patella resurfacing size 2 (k090988) lot 103391: (b)(4) items manufactured and released on 29-nov-2010.Expiration date: 2015-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM
• Common Device Name: 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15527285
• Report Number: 3005180920-2022-00743
• Device Sequence Number: 6078869
• Product Code: JWH
• UDI-Device Identifier: 07630030817717
• UDI-Public: 07630030817717
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• 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): 10/03/2022

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: 12/31/2015
• Device Model Number: 02.07.0412FUC
• Device Catalogue Number: 02.07.0412FUC
• Device Lot Number: 104103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female