MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED # 3+ L; FEMORAL CEMENTED COMPONENT

Catalog Number	02.12.0023L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2017.Lot 165045: (b)(4) items manufactured and released on 26 sept 2016.Expiration date: 2021-09-13 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.Gmk-sphere 02.12.0310fl tibial insert fixed flex #3/10 mm l (k121416): lot 164024: (b)(4) items manufactured and released on 14 sept 2016.Expiration date: 2021-09-04 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.Gmk-sphere 02.07.1203l tibial tray fixed cemented # 3 l (k090988): lot 164089: (b)(4) items manufactured and released on 29 sept 2016.Expiration date: 2021-09-15 no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.07.0033rp patella resurfacing # 1 (k090988) : lot.163382: (b)(4) items manufactured and released on 04 october 2016.Expiration date: 2021-09-18.No anomalies found related to the problem.To date, 54 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director on 13 december 2017: total knee revision surgery occurred 1 year after implantation.According to the report, the implant was in valgus position but this cannot be assessed having only post-revision x-rays.On the basis of available information, a proper clinical evaluation cannot be performed.
Event or Problem Description
The patient came in complaining of pain.The surgeon determined the patient presented with a valgus knee.The surgeon revised all medacta hardware.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED # 3+ L
• Common Device Name: FEMORAL CEMENTED COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7112597
• Report Number: 3005180920-2017-00738
• Device Sequence Number: 19141314
• Product Code: JWH
• UDI-Device Identifier: 07630030862373
• UDI-Public: 07630030862373
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2017

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: 09/13/2021
• Device Catalogue Number: 02.12.0023L
• Device Lot Number: 165045
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/13/2017
• 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