MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L; KNEE CEMENTED FEMORAL IMPLANT

Model Number	02.07.0033RP
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 december 2019.Lot 171205: (b)(4) items manufactured and released on 12-jun-2017.Expiration date: 2022-05-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in complaining of anterior knee pain 2 years and 3 months after primary.The surgeon plans to resurface the patella and a revision surgery has been scheduled for (b)(6) 2020.More details to follow once the case has been completed.
Additional Manufacturer Narrative
The patient came in reporting pain due to pain in the patella and showing signs of an infection.The surgeon revised the femoral component, poly, resurfaced the patella and added an extension stem 2 years and 8 months after primary.The surgery was completed successfully.Batch review performed on (b)(6) 2020: lot 168749: 50 items manufactured and released on (b)(6) 2017.Expiration date: 2022-04-04.No anomalies found related to the problem.To date, 47 items of the same lot have been already sold without any other similar reported event.Additional device involved: batch review performed on (b)(6) 2020: gmk-sphere 02.12.0310fl tibial insert fixed sphere flex size 3/10 mm l (k121416) lot 172775: 60 items manufactured and released on (b)(6) 2017.Expiration date: 2022-06-26.No anomalies found related to the problem.To date, 59 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting pain due to pain in the patella and showing signs of an infection.The surgeon revised the femoral component, poly, resurfaced the patella and added an extension stem 2 years and 8 months after primary.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L
• Common Device Name: KNEE CEMENTED FEMORAL IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9591143
• Report Number: 3005180920-2019-01139
• Device Sequence Number: 13576042
• Product Code: JWH
• UDI-Device Identifier: 07630030815737
• UDI-Public: 07630030815737
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 04/04/2022
• Device Model Number: 02.07.0033RP
• Device Catalogue Number: 02.12.0022L
• Device Lot Number: 168749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/24/2020
• 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