MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 R

Catalog Number	02.07.2204R
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 june 2018; lot 103681: (b)(4) items manufactured and released on 06 december 2010.Expiration date: 2015-11-30; no anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.
Event or Problem Description
Revision surgery performed due to pain, the femur malrotated, 6 years and 10 months after primary.The ps knee was revised with a semi-constrained knee.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 15 june 2018: partial revision (femoral) of a cemented tka in a heavy woman after 7 years due to malrotation problems.The patella is clearly out of the trochlea.This revision surgery was not originated by a defect in the device performance.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 R
• Common Device Name: FEMUR PS CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7560682
• Report Number: 3005180920-2018-00395
• Device Sequence Number: 2281712
• Product Code: JWH
• UDI-Device Identifier: 07630030820854
• UDI-Public: 07630030820854
• 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: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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: 11/30/2015
• Device Catalogue Number: 02.07.2204R
• Device Lot Number: 103681
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 07/13/2018
• 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: 54 YR
• Patient Weight: 97