MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION EXTENSION STEM - FLUTED Ø 13 L 105

Catalog Number	02.07.FCL13105
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 may 2018: lot 115705: (b)(4) items manufactured and released on 10 july 2012.Expiration date: 2017-05-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event clinical evaluation performed by medical affairs manager on 25 may 2018: the fixation screw securing the femoral component to the extension stem was found loosen in the joint.Patient details and date of implantation are not available.Screw removal and replacement is strongly recommended.During revision surgery, implant fixation and articular surfaces must be checked for integrity.The reason for self-unscrewing of the screw is not known: one possibility is insufficient tightening torque, but other unknown conditions may also play a role.
Event or Problem Description
On (b)(6) 2018 we were informed about a loosening of the screw from the connection between stem and femur.The post-op x-rays didn´t show a loosen screw.A revision surgery is planned, but the date is not defined.Patient's pain is not acute, the loosening of the screw maybe occured even 1 year ago.
Additional Manufacturer Narrative
On october 03, 2018 we were informed that we will not get the screw for further investigation.
Additional Manufacturer Narrative
On (b)(6) 2018 we were informed that the revision surgery is planed for (b)(6) 2018.On (b)(6) 2018 it was reported that the surgery was performed on (b)(6) 2018.Surgeon removed the screw, implanted a new screw and changed the inlay.

• Brand Name: GMK-REVISION EXTENSION STEM - FLUTED Ø 13 L 105
• Common Device Name: EXTENSION STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7544741
• Report Number: 3005180920-2018-00377
• Device Sequence Number: 11059541
• Product Code: JWH
• UDI-Device Identifier: 07630030822940
• UDI-Public: 07630030822940
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K120790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 05/31/2017
• Device Catalogue Number: 02.07.FCL13105
• Device Lot Number: 115705
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018; 04/27/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 07/06/2018; 10/08/2018
• 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: 50 YR