MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/17 MM R; KNEE TIBIAL INSERT

Catalog Number	02.12.0517FR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in for a post-op appointment and it was observed that the insert screw had backed out.It is unknown why this occurred.The surgeon revised the insert and the surgery was completed successfully.It is unknown if the torque limiter was used during primary surgery to place the screw into the liner.
Additional Manufacturer Narrative
Batch review performed on 13 march 2024: lot 144655: (b)(4) items manufactured and released on 03-nov-2014.Expiration date: 2019-aug-31.No anomalies found related to the problem.To date, (b)(4) 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: 8 years after primary cemented tka the insert securing screw was found out of its seating at a follow-up visit.No history was supplied so we could not determine the approximate date of the event.The agent reports that in their opinion no torque-limiting device was used at the time of primary surgery.The position of the screw at the time of follow-up xray is rather harmless: according to report, no damage was found on the articular surfaces and therefore the femoral component was left in place.One possible cause for spontaneous screw back out is insufficient tightening torque: this mechanism has been reproduced in the laboratory, but other causes may also play a role.It is very unusual that the screw backs out after such a long time: given the position of the screw at the time of follow-up xray, however, it is also possible that it stayed in that position for a long time.No adverse clinical consequences should be expected for the new configuration.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/17 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: 19049344
• Report Number: 3005180920-2024-00176
• Device Sequence Number: 18283990
• Product Code: JWH
• UDI-Device Identifier: 07630030826863
• UDI-Public: 07630030826863
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 04/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 02.12.0517FR
• Device Lot Number: 144655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2014
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White