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

Model Number	02.12.0003L
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 5 august 2021: lot 187132: 34 items manufactured and released on 14-nov-2018.Expiration date: 2023-nov-04.No anomalies found related to the problem.To date, 32 items of the same lot have been sold without any similar reported event.Additional item involved in the event, batch review performed on 5 august 2021: gmk-sphere 02.07.1202l tibial tray fixed cemented size 2 l (k090988) lot.181928 lot 181928: 32 items manufactured and released on 26-june-2018.Expiration date: 2023-june-14.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient had retropatellar complaint.It was found that the patient had nickel allergy.The primary prosthesis was well implanted.The patellar tendons were stuck together.Because of the allergy, the surgeon revised all implants 2 years and 5 months after the primary surgery.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12421320
• Report Number: 3005180920-2021-00698
• Device Sequence Number: 3726213
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

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: 11/04/2023
• Device Model Number: 02.12.0003L
• Device Catalogue Number: 02.12.0003L
• Device Lot Number: 187132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 09/03/2021
• 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: 63 YR