MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L; FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0003L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 june 2018: lot 167348: (b)(4) items manufactured and released on 13 march 2017.Expiration date: 2022-02-28 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-sphere tibial tray fixed cemented size 3 l reference 02.07.1203l (k090988): lot 170417: (b)(4) items manufactured and released on 14 june 2017.Expiration date: 2022-05-30 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.Tibial insert fixed sphere flex #3/12 mm l reference 02.12.0312fl (k121416): lot 165717: (b)(4) items manufactured and released on 14 november 2016.Expiration date:2021-10-27 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
Revision surgery because the extensor mechanism (quadriceps muscle group) was torn and implants mobilized.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7582496
• Report Number: 3005180920-2018-00407
• Device Sequence Number: 2514612
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2018

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: 02/28/2022
• Device Catalogue Number: 02.12.0003L
• Device Lot Number: 167348
• 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: 05/10/2018
• Initial Report FDA Received Date: 06/08/2018
• 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: 69 YR