MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0310FR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023 lot 2245056: 120 items manufactured and released on (b)(6) 2023.Expiration date: 2028-jan-25.No anomalies found related to the problem.To date, 66 items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by r&d manager: intraoperative failure of the connection between the tibial baseplate and the uhmwpe insert.Both the tibial insert and baseplate have been replaced with new ones.Visual inspection of the insert and baseplate, object of the event, sent back for investigation: the posterior feature of the insert intended to be engaged in the posterior dedicated seat of the baseplate has been damaged and slightly deformed in lateral side; it presents a sort of incision of the negative shape of the peripheral edge of the baseplate.Despite of the deformation, we were able to snap the insert into the baseplate.We guess that, in the attempts to fix the insert into the baseplate, the insert was not well positioned and not properly seated into the tibial tray.From visual inspection, there is no evidence that the event is related to a faulty device.Other devices involved: gmk-sphere 02.12.0310fr tibial insert fixed sphere flex size 3/10 mm r (k121416) lot 2302918: 120 items manufactured and released on 22-mar-2023.Expiration date: 2028-feb-29.No anomalies found related to the problem.To date, 34 items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot 2216945: 24 items manufactured and released on 08-nov-2022.Expiration date: 2027-oct-24.No anomalies found related to the problem.To date, 19 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Two 10mm liners (standard pe) could not be placed into the the tibial tray.Since the cement was not hard yet, and the origin of the problem was unknown, the tibial tray was explanted and a new one was placed.The surgery was completed using a 11mm liner (other 10 mm liners were not available).15 minutes delay occurred.Femur was not in place.

• Brand Name: GMK-SPHERE 02.12.0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R
• Common Device Name: KNEE TIBIAL INSERT
• 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: 17077534
• Report Number: 3005180920-2023-00398
• Device Sequence Number: 16706965
• Product Code: JWH
• UDI-Device Identifier: 07630030826344
• UDI-Public: 07630030826344
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/07/2023

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 Model Number: 02.12.0310FR
• Device Catalogue Number: 02.12.0310FR
• Device Lot Number: 2245056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2023
• 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: Unknown
• Patient Weight: 70 KG