MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED; KNEE TIBIAL TRAY CEMENTED

Catalog Number	02.07.2803L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Loss of Range of Motion (2032)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
About 8 months after the primary surgery, the patient came in for a post-op appointment reporting difficulties with range of motion.An allergic response is suspected, but the patient denies any rashes or itching in the area.The surgeon has no plans to revise the patient at this time.
Additional Manufacturer Narrative
Batch review performed on 18 july 2023 lot 2113382: 15 items manufactured and released on 08-feb-2022.Expiration date: 2027-jan-23.No anomalies found related to the problem.To date, 13 items of the same lot have been sold with no similar reported event during the period of review.Additional device received batch review performed on 18 july 2023: gmk-sphere 02.12.0723l femoral component sphere tinbn coated size 3+ l (k202684) lot 2118648: 25 items manufactured and released on 12-may-2022.Expiration date: 2027-may-02.No anomalies found related to the problem.To date, 20 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED
• Common Device Name: KNEE TIBIAL TRAY CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17412889
• Report Number: 3005180920-2023-00598
• Device Sequence Number: 7144892
• Product Code: JWH
• UDI-Device Identifier: 07630030821806
• UDI-Public: 07630030821806
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

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 Catalogue Number: 02.07.2803L
• Device Lot Number: 2113382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male