MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE FEMORAL COMPONENT; CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0007L
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 december 2017.Lot 152871: (b)(4) items manufactured and released on 23 june 2015.Expiration date: 2020-05-31.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 sphere tibial insert fixed flex #6/12 mm l ref.02.12.0612fl, lot.144617 (k121416): (b)(4) items manufactured and released on 06 oct 2014.Expiration date: 2019-08-31 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.Gmk tibial tray fixed cemented # 6 l ref.02.07.1206l, lot.142707 (k090988): (b)(4) items manufactured and released on 29 july 2014.Expiration date: 2019-06-30 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 primary extension stem ø11mm / l 30 mm ref 02.07.F11030 lot.153526 (k133630): (b)(4) items manufactured and released on 25 june 2015.Expiration date: 2018-02-28.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.
Event or Problem Description
Patient has reported pain and discomfort.Revision will occur on the (b)(6) 2017.More details to follow.
Additional Manufacturer Narrative
Information received by the sales agent on 22 february 2018 by the sales representative revision was performed on the (b)(6) 2017 and was completed successfully by changing the femoral component.Revision was required due to malalignment of the femoral component.This was due to excess cement mantle on the medial side of the implant.Clinical evaluation performed by medical affairs director on 27 february 2018 early partial revision (femoral component only, 9 months) of cemented tka.According to report, the cause is misalignment due to excessively thick cement mantle on the medial side.This problem is not related to a component malfunction or defect.

• Brand Name: GMK SPHERE FEMORAL COMPONENT
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7142937
• Report Number: 3005180920-2017-00766
• Device Sequence Number: 13678297
• Product Code: JWH
• UDI-Device Identifier: 07630030825897
• UDI-Public: 07630030825897
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121416
• 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,Followup
• Report Date (Section B): 03/23/2018

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: 05/31/2020
• Device Catalogue Number: 02.12.0007L
• Device Lot Number: 152871
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 03/23/2018
• 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