MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.07.1202R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At 5 years and 11 months from the primary, the patient came in reporting instability due to laxity and tibial component looseing.The cause is unknown.The surgeon revised the tibial tray and insert (from 12 to 14 mm).The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 30 jan 2024 lot 171951: (b)(4) items manufactured and released on 24-jul-2017.Expiration date: 2022-jul-06.No anomalies found related to the problem.To date, all items of the same lot have been sold with no other similar reported event during the period of review.Additional implant involved batch review performed on 30 jan 2024 on gmk-sphere 02.12.0212fr tibial insert fixed sphere flex size 2/12 mm r (k121416) lot.174799 lot 174799: (b)(4) items manufactured and released on 05-sept-2017.Expiration date: 2022-aug-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no other similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• 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: 18765738
• Report Number: 3005180920-2024-00056
• Device Sequence Number: 15360398
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2024

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: 07/06/2022
• Device Catalogue Number: 02.07.1202R
• Device Lot Number: 171951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2017
• 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: Female