MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 R

Model Number	02.12.0007R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-jan-2020.Lot 152886: (b)(4) items manufactured and released on 03-aug-2015.Expiration date: 30-jun-2020.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.Other devices involved in the event: gmk-sphere 02.12.0611fr tibial insert fixed sphere flex #6/11 mm r lot.186087 (k140826).Batch review performed on 08-jan-2020.Lot 186087: (b)(4) items manufactured and released on 15-nov-2018.Expiration date: 04-nov-2023.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.Gmk-sphere 02.07.1206r tibial tray fixed cemented # 6 r lot.171963 (k090988).Batch review performed on 08-jan-2020.Lot 171963: (b)(4) items manufactured and released on 21-sep-2017.Expiration date: 27-aug-2022.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 instability 3 months after primary surgery.The surgeon first trialed the 17mm sphere poly which improved stability in flexion and extension however, soft tissue instability in mid flexion range remained a major issue.The surgeon decided to convert all the sphere components (the femoral component, tibial tray, and insert) to a hinge knee in order to use augments and provide stability.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 R
• Common Device Name: FEMORAL COMPONENT SPHERE CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9610263
• Report Number: 3005180920-2019-01157
• Device Sequence Number: 547418
• Product Code: JWH
• UDI-Device Identifier: 07630030825903
• UDI-Public: 07630030825903
• 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: 2019
• 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): 01/21/2020

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: 06/30/2020
• Device Model Number: 02.12.0007R
• Device Catalogue Number: 02.12.0007R
• Device Lot Number: 152886
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/21/2020
• 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
• Patient Age: 81 YR