MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 5 RIGHT; KNEE FEMORAL COMPONENT CEMENTED

Catalog Number	02.09.2605R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second revision surgery underwent by the patient.He had a primary surgery on an unknown date, then he was revised on (b)(6) 2015 and now he was revised again.The pathogen is unknown.Batch reviews performed on 27 october 2017.(b)(4) items manufactured and released on 26 march 2014.Expiration date: 2019-02-28.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-hinge fixed tibial tray size 4 right, code 02.09.4004r, lot.146238 (k130299) (b)(4) items manufactured and released on 21 november 2014.Expiration date: 2019-10-31.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.Gmk-hinge fixed tibial insert size 4/17mm, code 02.09.0417h, lot.120026ar (k130299) (b)(4) items manufactured and released on 26 march 2014.Expiration date: 2017-03-31.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.Gmk-hinge offset connector 3 mm, code 02.07.0003, lot.148065 (k102437) (b)(4) items manufactured and released on 25 march 2015.Expiration date: 2020-02-29.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-hinge offset connector 5 mm, code 02.07.0005, lot.148697 (k102437) (b)(4) items manufactured and released on 15 april 2015.Expiration date: 2020-02-29.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-hinge extension stem - fluted ø 15 l 150, code 02.07.Fcl15150, lot.140435 (k120790) (b)(4) items manufactured and released on 28 april 2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on this lot.Gmk-hinge extension stem - cemented ø 13 l 105, code 02.07.Fsc13105, lot.115060 (k120790) (b)(4) items manufactured and released on 06 april 2012.Expiration date: 2017-02-28.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-hinge patella resurfacing size 3, code 02.07.0035rp, lot.145648 (k090988) (b)(4) items manufactured and released on 07 november 2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on this lot.Gmk-hinge femoral wedge posterior size 5/5mm, code 02.05.05pw, lot.142960 (k102437) (b)(4) items manufactured and released on 24 june 2014.Expiration date: 2019-05-31.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.Gmk-hinge femoral wedge distal size 5/12mm, code 02.07.512fdw, lot.110098 (k102437) (b)(4) items manufactured and released on 30 may 2011.Expiration date: 2016-04-30.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.Gmk-hinge tibial augmentation size 4/10mm, code 02.09.Ta410, lot.146737 (k130299) (b)(4) items manufactured and released on 25 november 2014.Expiration date: 2019-09-30.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.Gmk-hinge tibial augmentation size 4/10mm, code 02.09.Ta410, lot.112189 (k130299) (b)(4) items manufactured and released on 03 october 2011.Expiration date: 2016-08-31.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.
Event or Problem Description
Prosthesis was explanted due to a repeat infection.The complete prostheses has been explanted and a cement spacer with antibiotic has been put in.The pathogen is unknown.
Additional Manufacturer Narrative
Visual inspection of the explanted devices made on (b)(6) 2018 by the r&d project manager: gmk-hinge implants explanted 2 years and 1 month after previous revision surgery.The articular surfaces of the explanted pe liner were found regularly worn out.Bone cement was still adherent to the inner surfaces of the femoral component and its cemented extension stem and also to the distal plane of the two wedges.Extension stems were found well fixed to both femoral and tibial components.From the visual inspection was not possible to identify potential root causes of the infection for which the revision surgery was needed.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 5 RIGHT
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7040106
• Report Number: 3005180920-2017-00671
• Device Sequence Number: 2144819
• Product Code: KRO
• UDI-Device Identifier: 07630030825484
• UDI-Public: 07630030825484
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 02/28/2019
• Device Catalogue Number: 02.09.2605R
• Device Lot Number: 140413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 01/19/2018
• 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: 68 YR
• Patient Weight: 105