MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 2 RIGHT; KNEE FEMORAL COMPONENT

Catalog Number	02.09.2602R
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on (b)(6) 2017.Lot 162147: 17 items manufactured and released on (b)(6) 2016.Expiration date: (b)(6) 2021.No anomalies found related to the problem.To date, 7 items of the same lot have been already sold without any similar reported event.Gmk-hinge extension stem - fluted ø 16 l 65, code 02.07.Fcl16065, lot.162547 (k120790) 40 items manufactured and released on (b)(6) 2016.Expiration date: (b)(6) 2021.No anomalies found related to the problem.To date, 21 items of the same lot have been already sold without any similar reported event.Gmk-hinge fixed tibial insert size 2/12mm, code 02.09.0212h, lot.150741 (k130299) 20 inserts manufactured and released on (b)(6) 2015.Expiration date: (b)(6) 2020.No anomalies found related to the issue.To date, 13 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in complaining of limited range of motion.The patient had 40 degrees contracture following the primary tka with a gmk-hinge.Preoperative, the patient was 25 degrees contracture.The surgeon performed a femoral shortening, which allowed patient to have full range of motion, and revised the femur, poly and stem.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 2 RIGHT
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6851057
• Report Number: 3005180920-2017-00502
• Device Sequence Number: 19139663
• Product Code: KRO
• UDI-Device Identifier: 07630030825422
• UDI-Public: 07630030825422
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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: 04/20/2021
• Device Catalogue Number: 02.09.2602R
• Device Lot Number: 162147
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 09/08/2017
• 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