MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 1 / 10 MM; KNEE TIBIAL INSERT FIXED

Catalog Number	02.07.0110SF
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: 5 years after primary cruciate retaining tka the patient needs revision, suspected infection, then proved negative.The original tibial component is, at the time of revision, in suboptimal position, we do not know whether the component migrated in time or was original placed in this position.The exchange to a hinge prosthesis also suggest a progression of the disease, possibly involving collateral ligaments.We do not see any reason to suspect a faulty device.Batch review performed on 20 march 2019: lot 103345: (b)(4) items manufactured and released on 14-dec-2010.Expiration date: 2015-10-31.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.Additional component involved (not registered in us): gmk-primary 02.07.2301r femur std cementless size 1 r, lot 091651: (b)(4) items manufactured and released on 18-aug-2009.Expiration date: 2014-06-30.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.
Event or Problem Description
Patient presented with dissatisfaction and instability of the knee 4 years and 11 months after primary surgery.Surgeon was concerned around infection, so he decided to remove the knee.Intra operatively he found out that infection was negative.An hinge knee was implanted.

• Brand Name: GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 1 / 10 MM
• Common Device Name: KNEE TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8439900
• Report Number: 3005180920-2019-00177
• Device Sequence Number: 19597411
• Product Code: JWH
• UDI-Device Identifier: 07630030815928
• UDI-Public: 07630030815928
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2019

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: 10/31/2015
• Device Catalogue Number: 02.07.0110SF
• Device Lot Number: 103345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/21/2019
• 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: 69 YR
• Patient Weight: 75