MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L

Catalog Number	02.12.0004L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 january 2019: lot 176193: (b)(4) items manufactured and released on 04 january 2018.Expiration date: 2022-11-22.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.Gmk-sphere tibial insert fixed sphere flex size 4/10 mm reference (b)(4) (k121416) lot 176153: (b)(4) items manufactured and released on 08 january 2018.Expiration date: 2022-12-13.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.Gmk-sphere tibial tray fixed cemented size 4 reference (b)(4) (k090988) lot 176242: (b)(4) items manufactured and released on 20 december 2017.Expiration date: 2022-12-10.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.
Event or Problem Description
Revision surgery performed 9 months after primary due to infection.Pathogen is streptococcus oralis.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L
• Common Device Name: FEMORAL COMPONENT SPHERE CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8217189
• Report Number: 3005180920-2018-01062
• Device Sequence Number: 1670191
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

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: 11/22/2022
• Device Catalogue Number: 02.12.0004L
• Device Lot Number: 176193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2019
• 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: 81 YR
• Patient Weight: 90