MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/10MM; KNEE TIBIAL INSERT FIXED

Model Number	02.07.0210PSF
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 january 2020: lot 130214: (b)(4) items manufactured and released on 22-mar-2013.Expiration date: 2018-02-28.No anomalies found related to reported problems.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2017.Additional implant involved: gmk-primary 02.07.0033rp patella resurfacing size 1 (k090988) lot.124525.Batch review performed on 22 january 2020: lot 124525: (b)(4) items manufactured and released on 14-jan-2013.Expiration date: 2017-11-30.No anomalies found related to reported problems.To date, all items of the same lot have been already sold without any other similar reported event since 2017.
Event or Problem Description
The patient came in after 5 years and 8 months from the primary surgery reporting pain and instability.The cause of the pain was a loose patella and the cause of loose patella was liner instability.The surgeon revised the insert (to a thicker one) and patella successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/10MM
• Common Device Name: KNEE TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11292054
• Report Number: 3005180920-2021-00092
• Device Sequence Number: 4371609
• Product Code: JWH
• UDI-Device Identifier: 07630030816482
• UDI-Public: 07630030816482
• 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: 2015
• Device Explanted 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): 02/08/2021

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: 02/28/2018
• Device Model Number: 02.07.0210PSF
• Device Catalogue Number: 02.07.0210PSF
• Device Lot Number: 130214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/08/2021
• 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