MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/20MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0320PSF
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 october 2018; lot 178680: (b)(4) items manufactured and released on 24 jan 2018.Expiration date: 2023-01-11.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 components explanted: gmk-primary 02.07.2203l femur ps cemented # 3 l (k090988) lot.135492: (b)(4) items manufactured and released on 16 dec 2013.Expiration date: 30-11-2018.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.Gmk-primary 02.07.1203l tibial tray fixed cemented # 3 l (k090988) lot.180254: (b)(4) items manufactured and released on 15 may 2018.Expiration date: 2023-05-03.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
After surgery, the surgeon determined that the leg was hyperextended.Revision surgery was performed 2 days after the primary.The surgeon removed all hardware and implanted new medacta hardware, he opted to a cck because the mcl and lcl were deficient.Revision surgery successfully performed.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/20MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7946596
• Report Number: 3005180920-2018-00762
• Device Sequence Number: 2255363
• Product Code: JWH
• UDI-Device Identifier: 07630030817489
• UDI-Public: 07630030817489
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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: 01/11/2023
• Device Catalogue Number: 02.07.0320PSF
• Device Lot Number: 178680
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2018
• Initial Report FDA Received Date: 10/09/2018
• 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: 79 YR