MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L; KNEE TIBIAL INSERT FLEX

Catalog Number	02.12.0414FL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During revision surgery, the surgeon performed 14mm insert trial and attempted to insert a 14mm insert, but it would not fit.A 13mm insert was used and the surgery was completed successfully.The delay time is 50min and the total surgery time is 2hr.
Additional Manufacturer Narrative
Batch review performed on 11 september 2023: lot 1910172: (b)(4) items manufactured and released on 10-jan-2020.Expiration date: 2024-12-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional involved product: batch review performed on 04 october 2023 on gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot.2116001.Lot 2116001: (b)(4) items manufactured and released on 12-apr-2022.Expiration date: 2027-03-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Additional Manufacturer Narrative
Additional information received: - piece returned on the 13th of october 2023 - visual inspection performed by r&d project manager: the insert looks damaged in its posterior feature intended to be engaged in the dedicated seat of the baseplate on the medial side.It presents a sort of incisions of the negative shape of the peripheral edge of the baseplate also the bottom surface of the insert presents lot of dents in the postero-medial part.We guess that, in the first attempts to fix the insert into the baseplate, the insert was not well positioned and not properly seated into the tibial tray.In this attempt the insert was damaged precluding the possibility to fix the insert in the following attempts.From visual inspection, there is no evidence that the event is related to a faulty device.Corrections: - b1 field: insertion of "product problem", previously it was reported "adverse event" - b2 field: insertion of "other serious or important medical events" , previously it was reported "required intervention to prevent permanent impairment/damage" - h1 field: insertion of "malfunction" and not "serious injury.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L
• Common Device Name: KNEE TIBIAL INSERT FLEX
• 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: 17868423
• Report Number: 3005180920-2023-00751
• Device Sequence Number: 20321874
• Product Code: JWH
• UDI-Device Identifier: 07630030826610
• UDI-Public: 07630030826610
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2024
• Device Catalogue Number: 02.12.0414FL
• Device Lot Number: 1910172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2020
• 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: Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian