MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/14MM; TIBIAL INSERT FIXED

Model Number	02.07.0314PSF
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 march 2021: lot 188114: 30 items manufactured and released on 29-nov-2018.Expiration date: 2023-11-12.No anomalies found related to the problem.To date, 26 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
1 year and 5 months after primary the patient came in reporting instability and the cause of the instability is unknown.The surgeon plans on revising the insert to give the patient more stability.A revision surgery has not been scheduled at this time.More details to follow once information becomes available.
Event or Problem Description
1 year and 5 months after primary the patient came in reporting instability and the cause of the instability is unknown.The surgeon resurfaced the patient's natural patella and revised the insert height (from 14mm to 17mm).The surgery was completed successfully.
Additional Manufacturer Narrative
On 06-may-2021 we received new information about this case.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/14MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11641933
• Report Number: 3005180920-2021-00278
• Device Sequence Number: 11510097
• Product Code: JWH
• UDI-Device Identifier: 07630030817267
• UDI-Public: 07630030817267
• 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: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: 11/12/2023
• Device Model Number: 02.07.0314PSF
• Device Catalogue Number: 02.07.0314PSF
• Device Lot Number: 188114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/04/2021
• 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: 75 YR