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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/08/2024

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 339443030
• Report Number: 3005180920-2024-00176
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826863
• UDI-Public: 07630030826863
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 02.12.0517FR
• Device Lot Number: 144655
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White