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

Catalog Number	02.12.0024L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 october 2018.Lot 180312: 120 items manufactured and released on 03 october 2017.Expiration date: 2022-09-24.No anomalies found related to the problem.To date, 102 items of the same lot have been already sold without any similar reported event.Gmk-sphere patella resurfacing size 2 reference: 02.07.0034rp.Lot 180312: 120 items manufactured and released on 03 october 2017.Expiration date: 2022-09-24.No anomalies found related to the problem.To date, 102 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 1 month after primary the surgeon revised the patient knee for patella dislocation.The surgeon revised the femur component which allowed the patella to relocate and track properly.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7938072
• Report Number: 3005180920-2018-00755
• Device Sequence Number: 11347245
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

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: 04/25/2023
• Device Catalogue Number: 02.12.0024L
• Device Lot Number: 180340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/05/2018
• 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