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

Catalog Number	02.12.0003R
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 april 2019: lot 155205: (b)(4) items manufactured and released on 16-dec-2015.Expiration date: 2020-11-29.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.Additional implants revised: gmk-sphere 02.12.0310fr tibial insert fixed sphere flex size 3/10 mm r, ( k121416) lot 152933: (b)(4) items manufactured and released on 23-sep-2015.Expiration date: 2020-08-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.07.1203r tibial tray fixed cemented size 3 r, (k090988) lot 156117: (b)(4) items manufactured and released on 26-jan-2016.Expiration date: 2021-01-11.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 performed, 2 years and 10 months ago, due to pain.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R
• Common Device Name: KNEE FEMORAL CEMENTED COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8522870
• Report Number: 3005180920-2019-00286
• Device Sequence Number: 1884944
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

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: 11/29/2020
• Device Catalogue Number: 02.12.0003R
• Device Lot Number: 155205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/17/2019
• 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: 70 YR
• Patient Weight: 88