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

Catalog Number	02.07.1202R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13-jul-2023 lot 1908613: 79 items manufactured and released on 18-mar-2020.Expiration date: 2025-03-10.No anomalies found related to the problem.To date, 78 items of the same lot have been sold with no similar reported event during the period of review.Additional device involved batch review performed on 13-jul-2023 gmk-sphere 02.12.0212fr tibial insert fixed sphere flex size 2/12 mm r (k121416) lot 189036: 90 items manufactured and released on 20-feb-2019.Expiration date: 2024-02-10.No anomalies found related to the problem.To date, 68 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs director: at 3 years after primary cemented tka a revision is needed.The tibial tray is medially offset and possibly undersized, it eventually got loose.The femoral component was possibly in a flexed position, but it was stable and the surgeon decided to leave it in place.The causes for loosening may be related to the observations made above, listed in the product literature among the causes that may lead to early loosening of the implant.
Event or Problem Description
At about 3 years from the primary, revision surgery due to cemented tibial plate loosening.The surgeon revised the tibial tray and the insert (from 12 to 13 mm).Tibial components revised successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R
• Common Device Name: KNEE 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: 17412888
• Report Number: 3005180920-2023-00584
• Device Sequence Number: 12548883
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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 Expiration Date: 03/10/2025
• Device Catalogue Number: 02.07.1202R
• Device Lot Number: 1908613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2020
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 92 KG