MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ RIGHT

Catalog Number	02.12.0025R
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 17 august 2017.Lot 152916: (b)(4) items manufactured nad released on 03 june 2015.Expiration date 2020-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without ay similar reported event.Gmk-sphere tibial tray fixed cemented size 4 right, code 02.07.1204r, lot.150355 (k090988) (b)(4) items manufactured nad released on 12 may 2015.Expiration date 2020-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without ay similar reported event.Gmk-sphere tibial insert fixed flex size 4/10 mm right, code 02.12.0410fr, lot.147675 (k121416) (b)(4) items manufactured nad released on 28 may 2015.Expiration date 2020-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without ay similar reported event.Gmk-sphere patella resurfacing size 2, code 02.07.0034rp, lot.150872 (k090988) (b)(4) items manufactured nad released on 07 july 2015.Expiration date 2020-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without ay similar reported event.
Event or Problem Description
The patient came in due to sign of infection.The patient was positive for strep.The surgeon removed all medacta hardware and implanted a spacer on an unknown date.On (b)(6) 2017 the surgeon removed the spacer and implanted permanent medacta product.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ RIGHT
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6800100
• Report Number: 3005180920-2017-00447
• Device Sequence Number: 1247843
• Product Code: JWH
• UDI-Device Identifier: 07630030862427
• UDI-Public: 07630030862427
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2017

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: 04/30/2020
• Device Catalogue Number: 02.12.0025R
• Device Lot Number: 152916
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/17/2017
• 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