MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L; CEMENTED FEMORAL KNEE

Catalog Number	02.12.0024L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 march 2019: lot 165985: (b)(4) items manufactured and released on 28-nov-2016.Expiration date: 2021-11-15.No anomalies found related to the problem.To date, (b)(4) items of this lot have been already sold without any similar reported event.Additional implant involved, not available for further investigation: gmk-sphere 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l (k121416), lot.141017:50 items manufactured and released on 10-apr-2014.Expiration date: 2019-02-28.No anomalies found related to the problem.To date, all the items of this lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of infection about 2 years after primary, the pathogen is unknown.The surgeon performed a washout and revised the femoral component and poly.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L
• Common Device Name: CEMENTED FEMORAL KNEE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8428914
• Report Number: 3005180920-2019-00166
• Device Sequence Number: 13788270
• Product Code: JWH
• UDI-Device Identifier: 07630030862397
• UDI-Public: 07630030862397
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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: 11/15/2021
• Device Catalogue Number: 02.12.0024L
• Device Lot Number: 165985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/18/2019
• 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