MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/12MM

Model Number	02.07.0512PSF
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 december 2020: lot 136097: (b)(4) items manufactured and released on 10-feb-2014.Expiration date: 2018-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2016.Clinical evaluation performed by medacta medical affairs department: secondary resurfacing of patella in a tka performed 4 years and 8 months before.A secondary patella resurfacing should not be considered a failure: sometimes surgeons prefer to postpone patella arthroplasty in order to preserve maximum quantity of bone and reduce trauma, and proceed to treat only in case of persistent anterior pain.In the same surgery, the insert was exchanged to a thicker one.The developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.It is therefore common practice to resort to a thicker insert and recreate soft tissue tension.This is not a problem due to any implant defect or malfunction.Additional device involved lot number is not available.
Event or Problem Description
Right knee gmk primary inlay change from 12mm to 17mm and patella implant installation after 4 years and 8 months from the primary(6 apr 2016) surgery due to knee instability.Left knee gmk sphere inlay change from 12mm to 17mm after 1 year and 8 months from the primary(15 may 2019) surgery due to knee instability.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/12MM
• Common Device Name: TIBIAL INSERT PS FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11130578
• Report Number: 3005180920-2021-00011
• Device Sequence Number: 11574962
• Product Code: JWH
• UDI-Device Identifier: 07630030818325
• UDI-Public: 07630030818325
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• 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): 01/07/2021

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: 12/31/2018
• Device Model Number: 02.07.0512PSF
• Device Catalogue Number: 02.07.0512PSF
• Device Lot Number: 136097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 01/07/2021
• 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: 67 YR