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

Catalog Number	02.12.0004R
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 december 2018: lot 167359: (b)(4) items manufactured and released on 09 march2017.Expiration date: 2022-02-27.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.Other device involved: gmk-sphere tibial insert fixed sphere flex size 4/17 mm r reference 02.12.0417fr (k121416).Lot 168359: (b)(4) items manufactured and released on 23 february 2017.Expiration date: 2022-02-08.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 t3-i4 r reference 02.12.T3i4r.Lot 168376: (b)(4) items manufactured and released on 20 march 2017.Expiration date: 2022-07-03.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 patella resurfacing size 2 reference 02.07.0034rp (k090988).Batch review performed on 18 december 2018: lot 170489: (b)(4) items manufactured and released on 10 may 2017.Expiration date: 2022-04-24.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
The patient had a primary total knee surgery on (b)(6) 2017.The patient now reports that she is experiencing pain and discomfort that causes her to be unable to walk, 4 months after primary.No additional details are available.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8178703
• Report Number: 3005180920-2018-01014
• Device Sequence Number: 19322698
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2018

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: 02/27/2022
• Device Catalogue Number: 02.12.0004R
• Device Lot Number: 167359
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/19/2018
• 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