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

Model Number	02.12.0002L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2020: lot 136412: (b)(4) items manufactured and released on 05 february 2014.Expiration date: 2018-12-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2016.Additional implant involved: gmk-sphere 02.07.1202l tibial tray fixed cemented size 2 l (k090988) lot.151425.Batch review performed on 02 july 2020: lot 151425: (b)(4) items manufactured and released on 12 may 2015.Expiration date: 2020-03-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2016.Additional implant involved: gmk-sphere 02.12.0220fl tibial insert fixed sphere flex size 2/20 mm l (k121416) lot.135184.Batch review performed on 02 july 2020: lot 135184: (b)(4) items manufactured and released on 16 jan 2014.Expiration date: 2018-11-30.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 since 2016.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2015.Subsequently, the patient came in reporting instability due to laxity.On (b)(6) 2017, the surgeon revised the 14mm poly with a 20mm poly.Presently, the patient came in reporting pain and instability due to laxity.The surgeon plans to revise all implants and a revision surgery has been scheduled for (b)(6) 2020.
Additional Manufacturer Narrative
The revision surgery was completed successfully on the (b)(6) 2020.The surgeon revised the femoral component, tibial tray, and insert and replaced them with a gmk-hinge knee.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10229321
• Report Number: 3005180920-2020-00384
• Device Sequence Number: 573295
• Product Code: JWH
• UDI-Device Identifier: 07630030825798
• UDI-Public: 07630030825798
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/04/2020

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: 12/31/2018
• Device Model Number: 02.12.0002L
• Device Catalogue Number: 02.12.0002L
• Device Lot Number: 136412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 09/04/2020
• 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